136 Regulatory Affairs Specialists jobs in Singapore

Job Description & Requirements

This position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other industries. The Regional Regulatory Affairs teams support the regional and global compliance programs across IFF product lines. Deep regulatory knowledge of the applicable regulatory requirements for the specific products in their intended applications allows the teams to provide the regulatory support to our internal and external stakeholders so that our products comply with the applicable regulations.

We are now looking for a dynamic talent to join our Singapore team as Senior Regulatory Affairs Specialist.

Your Focus

As Senior Regulatory Affairs Specialist, you will be responsible for the management of registrations, compliance or safety and risk assessment for Animal Nutrition in Southeast Asia. You will work closely with IFF Global, Regional, Country regulatory affairs team and business stakeholders, to achieve IFF objectives.

The role will see you provide accurate understanding and interpretation of relative regulations and the capacity of regulatory knowledge development to explain and defend positions. The Senior Regulatory Affairs Specialist will be a crucial part of Bioscience overall regulatory compliance structure and team. You must ensure compliance within the area of responsibility and support as Key liaison with equivalent roles in the region, to ensure a coherent, consistent strategy on a global basis.

The role will report into the Bioactive Asia Pac Regulatory Affairs Director.

How You Will Contribute

The responsibilities will be progressing over time, and include (but are not limited to) the following:

• Preparing product registration dossiers for new approvals and renewals, monitor and follow up process.
• Maintain expert knowledge on local regulatory procedures to ensure compliance and regulatory requirements and timelines are met.
• Develops and maintain relationships with relevant regional competent authorities and trade associations.
• Maintain close interaction with regional business teams to identify needs, align on Regional objectives and prioritize the efforts, while incorporating Global needs.
• May evaluate regulatory implications of product and process changes.
• Provides Regional strategic input to Global strategies and innovation.
• Is responsible for regional execution of Global strategies in alignment with Regional Commercial teams.

What You Will Need To Be Successful

• Bachelor degree in Life Sciences, Biotechnology, Science or any other relevant discipline.
• At least 3 years of Regulatory experience in Food and Feed industry.
• Strong experience in Regulatory Affairs management of registrations, compliance or safety and risk assessment.
• Deep regulatory knowledge of the applicable regulatory requirements specifically Animal Nutrition products in Southeast Asia.
• Sound knowledge of Regulatory Affairs including:
• Product registration dossiers
• Regulatory procedures, compliance and regulatory requirements
• Evaluation of regulatory implications of product and process changes
• Capacity of regulatory knowledge development to explain and defend positions.
• Proficiency in English communication skills. Fluency in secondary local language will be advantageous.
• An effective team player, ability to coordinate and collaborate effectively with stakeholders.
• Proactive and self-driven approach to continuous improvement.
• Logical, methodical, and analytical thought processes.
• Accuracy and attention to details with agility to adapt in changing environment.
• Technical problem-solving skills with the ability to influence.
• Good prioritization, planning, time management and organizing skills.
• Comfortable with IT System or Applications.

We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.

Visit IFF.com/careers/workplace-diversity-and-inclusion to learn more

Job Description & Requirements

This position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other industries. The Regional Regulatory Affairs teams support the regional and global compliance programs across IFF product lines. Deep regulatory knowledge of the applicable regulatory requirements for the specific products in their intended applications allows the teams to provide the regulatory support to our internal and external stakeholders so that our products comply with the applicable regulations.

We are now looking for a dynamic talent to join our Singapore team as Senior Regulatory Affairs Specialist.

Your Focus

As Senior Regulatory Affairs Specialist, you will be responsible for the management of registrations, compliance or safety and risk assessment for Animal Nutrition in Southeast Asia. You will work closely with IFF Global, Regional, Country regulatory affairs team and business stakeholders, to achieve IFF objectives.

The role will see you provide accurate understanding and interpretation of relative regulations and the capacity of regulatory knowledge development to explain and defend positions. The Senior Regulatory Affairs Specialist will be a crucial part of Bioscience overall regulatory compliance structure and team. You must ensure compliance within the area of responsibility and support as Key liaison with equivalent roles in the region, to ensure a coherent, consistent strategy on a global basis.

The role will report into the Bioactive Asia Pac Regulatory Affairs Director.

How You Will Contribute

The responsibilities will be progressing over time, and include (but are not limited to) the following:

• Preparing product registration dossiers for new approvals and renewals, monitor and follow up process.
• Maintain expert knowledge on local regulatory procedures to ensure compliance and regulatory requirements and timelines are met.
• Develops and maintain relationships with relevant regional competent authorities and trade associations.
• Maintain close interaction with regional business teams to identify needs, align on Regional objectives and prioritize the efforts, while incorporating Global needs.
• May evaluate regulatory implications of product and process changes.
• Provides Regional strategic input to Global strategies and innovation.
• Is responsible for regional execution of Global strategies in alignment with Regional Commercial teams.

What You Will Need To Be Successful

• Bachelor degree in Life Sciences, Biotechnology, Science or any other relevant discipline.
• At least 3 years of Regulatory experience in Food and Feed industry.
• Strong experience in Regulatory Affairs management of registrations, compliance or safety and risk assessment.
• Deep regulatory knowledge of the applicable regulatory requirements specifically Animal Nutrition products in Southeast Asia.
• Sound knowledge of Regulatory Affairs including:
• Product registration dossiers
• Regulatory procedures, compliance and regulatory requirements
• Evaluation of regulatory implications of product and process changes
• Capacity of regulatory knowledge development to explain and defend positions.
• Proficiency in English communication skills. Fluency in secondary local language will be advantageous.
• An effective team player, ability to coordinate and collaborate effectively with stakeholders.
• Proactive and self-driven approach to continuous improvement.
• Logical, methodical, and analytical thought processes.
• Accuracy and attention to details with agility to adapt in changing environment.
• Technical problem-solving skills with the ability to influence.
• Good prioritization, planning, time management and organizing skills.
• Comfortable with IT System or Applications.

We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.

Visit IFF.com/careers/workplace-diversity-and-inclusion to learn more

We are seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory strategies, to ensure timely submissions, enabling timely product approvals and lifecycle management for our product portfolio in Singapore. The ideal candidate will serve as the primary point of contact for Health Sciences Authority (HSA) in all matters related to RA/QA and fostering strong collaboration with internal stakeholders.

Primary duties and responsibilities

Regulatory Affairs:

• Develop and execute regulatory strategies to ensure timely product registrations, variations and renewals in Singapore.
• Prepare, compile, review, and submit regulatory dossiers in accordance with HSA requirements.
• Maintain regulatory compliance across the product lifecycle, including handling variations, labelling updates, and post-marketing requirements.
• Act as the primary liaison with HSA and other relevant regulatory bodies; manage communications and negotiations effectively.
• Monitor and interpret regulatory guideline, policies, and trends; assess impact and communicate changes to stakeholders.
• Collaborate with cross-functional teams (RA, QA, PV, Medical, Commercial, etc.) to support business objectives and ensure regulatory alignment for timely product launch and supply continuity.
• Provide regulatory input in product development, promotional material reviews, and new product evaluations.
• Maintain up-to-date regulatory files and tracking systems for all submissions and approvals.

Quality Assurance:

• Oversee local quality activities to ensure compliance with HSA’s Good Distribution Practice (GDP) and other relevant guidelines.
• Maintain and update the local Quality Management System (QMS), including SOPs and records.
• Ensure timely reporting and resolution of quality incidents, product complaints, and deviations.
• Coordinate with global QA for quality audits, inspections, and CAPA implementation.
• Ensure compliance with local pharmacovigilance requirements, including timely reporting of adverse events (AEs), serious adverse events (SAEs), and product quality complaints to HSA.
• Perform any other ad-hoc duties as and when assigned by the Company.

Qualifications

Knowledge/Experience:

• Must be a licensed pharmacist in Singapore.
• Bachelor’s degree in Pharmacy, Life Sciences, or a related field. Advanced degree is a plus.
• Minimum 7-10 years of regulatory affairs experience in the pharmaceutical, biotech, medical device or healthcare industry, preferably within Singapore.
• Strong knowledge of HSA regulations and regulatory submission requirements including RA, GDP and PV.
• Proven experience in leading product registrations and acting as the primary contact for HSA.
• Excellent communication, and ability to collaborate across cross-functional teams.
• High level of integrity, detail-orientation, and critical thinking skills.
• Ability to work independently and manage multiple projects in a dynamic environment.

Preferred Qualifications:

• In-depth knowledge of HSA drug and medical device regulatory processes and regulations, ASEAN and ICH guidelines, and international regulatory standards.
• Previous experience of verification pathway, ACCESS or Project orbis would be preferred.
• Experience with digital regulatory tools and quality systems is a plus.
• Membership or certification in professional bodies such as RAPS, SAPI, ISPE, or similar is desirable.
• Proficiency in English (written and spoken) is a must. Fluency in Mandarin (written and spoken) is a plus.

Your gateway to rxilient,
Get in touch with us #J-18808-Ljbffr

Summary

Ensure that cosmetic products meet all applicable regulations. Collect and submit to the local authority documents required for licenses and renewals following strict deadlines. Follow up and set timelines for approvals. Protect Brands from any regulatory risk of non-compliance. Monitor existing and new regulations to anticipate any business impact. The role requires a proactive individual who can manage submissions, track progress, and communicate effectively with both regulatory authorities and internal stakeholders.

Responsibility

1. Regulatory Submissions:

• Prepare, coordinate, and submit regulatory dossiers/packaging data to the local authorities in Singapore.

• Track submission progress and proactively address any queries or requests from the authorities.

• Provide timely updates, monthly reports, and KPI reports on submission status to the Regulatory Affairs Manager in Singapore.

2. Documentation and Database Management:

• Compile, organize, and maintain comprehensive regulatory documentation, including the source of product registration and approvals.

• Ensure that accurate and up-to-date regulatory information is maintained in relevant databases and systems.

3. Compliance Support:

• Marketing claims: Maintain a current and accurate list of permitted and prohibited claims in accordance with local regulations. Review and ensure product claim compliance.

• Label: Ensure that all product labels comply with local labelling regulations and requirements.

• Inspection: Participate in local regulatory inspections, including preparation and follow-up activities.

• Non-compliance reporting: Immediately report any identified regulatory risks or instances of non-compliance.

4. Regulatory Monitoring:

• Monitor new regulations and guidelines relevant to the company's products.

• Provide timely updates and summaries of regulatory changes to the Regulatory Affairs Manager and relevant stakeholders.

• Assess the potential impact of new regulations on the company's products and operations.

Reporting

• Locally: SEA Regulatory Manager

Knowledge & Attributes Required

• Diploma/degree with science background.

• 1-2 years of relevant working experience in regulatory affairs is preferred.

• Excellent time management skills with the ability to thrive in a fast-paced environment.

• A collaborative team player with strong interpersonal skills.

• Meticulous with high level of accuracy.

• Excellent communication skills, both written and verbal.

#J-18808-Ljbffr

To combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has division level influence and responsibility and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual will be actively called upon to influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.

Main Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Strategic Planning:

• Identify need for new regulatory policies, processes and SOPs and approve them.

• Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.

• Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.

• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.

• Develop global regulatory strategies and update based upon regulatory changes.

• Anticipate emerging issues and develop solutions to them.

• Develop solutions to address issues with other members of management and stakeholders.

• Develop corporate positions on regulatory risk-benefit.

• Create and develop product positioning strategies based upon regulatory requirements.

• Integrate regulatory considerations into the corporation’s global product entry and exit strategy.

• Provide guidance for resource and development planning.

• Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies Pre-market.

• Communicate application progress to internal stakeholders.

• Negotiate with regulatory authorities during the development and review process to ensure submission approval.

• Provide strategic input and technical guidance on regulatory requirements to development teams.

• Ensure pre-approval compliance activities are completed.

• Formulate company procedures to respond to regulatory authority queries postmarked.

• Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.

• Ensure a system is in place to manage access to information requests.

• Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.

• Identify and present option for risk mitigation to decision makers.

• Ensure adverse events are reported to regulatory agencies and internal stakeholders.

• Manage processes involved with maintaining annual licenses, registrations, listings and patent information.

• Ensure compliance with product post-marketing approval requirements.

• Review and approve advertising and promotional items to ensure regulatory compliance.

Job specific responsibilities may include

• Country-specific regulatory support, including the SEA market.

Accountability

• Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies.

• Must assure that all deadlines are met and provide effective leadership without direct authority.

• Individual is recognized as a key opinion leader and resource in regulatory affairs.

Influence/Leadership:

• Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation

• Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives

• Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units

• May lead a project team or initiative within department or cross-functions/divisions

• Provides technical leadership to business units

• Exercises judgment independently

• Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives

• May participate / lead external industry working groups to influence advocacy in alignment with business strategies

Planning/Organization:

• Creates mid- to long-range plans to carry out objectives established by top management

• Develops and calculates a budget for one or more departments to meet organizational goals

• Forecasts future departmental or group needs including human and material resources and capital expenditures

• Determines and establishes organizational structure and supervisory relationships subject to top management approval

Decision Making/Impact:

• Assignments are expressed in the form of objectives

• Work is performed without appreciable direction

• Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.

• Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity

Requirements

• Bachelor's degree (or equivalent); bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 12+ years’ experience in a regulated industry (e.g., medical products, nutritional). 12+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

• Regulatory history, guidelines, policies, standards, practices, requirements and precedents

• Regulatory agency structure, processes and key personnel

• Principles and requirements of applicable product laws

• Submission/registration types and requirements

• GxPs (GCPs, GLPs, GMPs)

• Principles and requirements of promotion, advertising and labeling

• International treaties and regional, national, local and territorial trade requirements, agreements and considerations

• Domestic and international regulatory guidelines, policies and regulations

• Ethical guidelines of the regulatory profession, clinical research and regulatory process.

• Monitor costs of projects and of human and material resources within a department or unit

• Monitor company-wide indicators such as market share and profitability

• Develop least cost, least time means to provide optimal regulatory support for new products

• Monitor external environment in area of technical or professional responsibility

• Direct and manage the preparation of technical strategic regulatory documentation for agency submission

• Communicate effectively verbally and in writing

• Communicate with diverse audiences and personnel

• Work with cross-functional teams

• Work with people from various disciplines and cultures

• Write and edit technical documents

• Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies

• Negotiate internally and externally with regulatory agencies and participate in political lobbying

• Plan and conduct meetings

• Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks

• Effectively negotiate regulatory agreements with global regulatory agencies

• Negotiate regulatory and scientific issues with management

• Adjust presentation style and content to suit the audience

#J-18808-Ljbffr

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac, PediaSure, Pedialyte, Ensure, Glucerna and ZonePerfect – to help get the nutrients they need to live their healthiest life.

The Opportunity

Our location in Singapore currently has an opportunity for a RA Manager – Regulatory Intelligence, specifically supporting the Pacific Asia / China region.

This position will manage compliance-related activities and assessments and lead multiple associated medium to large-scale projects that support Abbott Nutrition’s Regulatory Affairs strategic and compliance objectives.

This regional position will independently interface with Abbott affiliates, AN Division, AN manufacturing plants, R&D, Quality, Supply Chain, and others. Success will depend on leadership in managing the process, governance, and resources required to timely assess market signals that impact the Abbott Nutrition business. The position will achieve the objectives through effective communication, and strong interpersonal and presentation skills.

WHAT YOU’LL DO

• Lead regional regulatory intelligence operations, coordinate with Pacific Asia/China Commercial Affiliates to monitor and assess impact to approved and draft regulations/standards.
• Represent relevant region as regulatory subject matter expert for regulation impact to AN business. Responsible for identifying and managing critical emerging regulations, and timely communication to senior leadership.
• Provide clear and consistent communication, both oral and written, to all project stakeholders on key project elements such as scope, timeline, issues, etc.
• Support cross-functional project timelines and follow up with project team members to ensure timely completion of tasks.
• Recommend changes to policies, procedures, and systems that will ensure AN and market compliance requirements are met.
• Recommend and implement strategies and enhancements to improve efficiency.

Accountability/Scope

• The compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-term impact on our business. This position will work with limited supervision.

Requirements

• Bachelor’s degree in a relevant discipline/or equivalent work experience is required (Chemistry, Microbiology, Nutrition/Dietetics, Food Science, Engineering, Business Administration).
• A Master’s degree is preferred.
• 5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Regulatory, Quality, R&D, Project Management, Procurement or Operations function, with good knowledge of food and nutrition regulations.
• 3-5 years’ experience in project roles.
• Critical thinking/problem-solving skills.
• Ability to plan and facilitate meetings.
• Effective Stakeholder Management.
• Ingredient expertise, process expertise, and formulation expertise in nutritional and infant concepts.
• Well-developed interpersonal, communication, and negotiation skills.
• Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.). Change management.
• Sound decision-making skills contributing to high levels of competence, confidence, and credibility are required.
• Cross-functional/cross-divisional experiences.
• Experience dealing with international locations.

#J-18808-Ljbffr

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**The Opportunity**
Our location in Singapore currently has an opportunity for a **RA Manager - Regulatory Intelligence,** specifically supporting the Pacific Asia / China region.
This position will manage compliance related activities and assessments and lead multiple associated medium to large-scale projects that support Abbott Nutrition's Regulatory Affairs strategic and compliance objectives.
This regional position will independently interface with Abbott affiliates, AN Division, AN manufacturing plants, R&D, Quality, Supply Chain and others. Success will depend on leadership in managing the process, governance and resources required to timely assess market signals that impact the Abbott Nutrition business. The position will achieve the objectives through effective communication, and strong interpersonal and presentation skills.
**WHAT YOU'LL DO**
+ Lead regional regulatory intelligence operations, coordinate with Pacific Asia/China Commercial Affiliates to monitor and assess impact to approved and draft regulations/standards
+ Represent relevant region as regulatory subject matter expert for regulation impact to AN business. Responsible for identifying and managing critical emerging regulations, and timely communication to senior leadership.
+ Provide clear and consistent communication, both oral and written to all project stakeholders on key project elements such as scope timeline, issues, etc.
+ Support cross-functional project timelines and follow up with project team members to ensure timely completion of tasks.
+ Recommend changes to policies, procedures and systems that will ensure AN and market compliance requirements are met.
+ Recommend and implement strategies and enhancements to improve efficiency.
**Accountability/Scope**
+ The compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-term impact on our business. This position will work with limited supervision.
**Requirements**
+ Bachelor's degree in a relevant discipline/or equivalent work experience is required (Chemistry, Microbiology, Nutrition/Dietetics, Food Science, Engineering, Business Administration)
+ A Master's degree is preferred.
+ 5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Regulatory, Quality, R&D, Project Management, Procurement or Operations function and good knowledge of food and nutrition regulations.
+ 3-5 years' experience in project roles.
+ Critical thinking/problem-solving skills.
+ Ability to plan and facilitate meetings.
+ Effective Stakeholder Management.
+ Ingredient expertise, process expertise, and formulation expertise in nutritional and infant concepts.
+ Well-developed interpersonal, communication and negotiation skills.
+ Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.). Change management.
+ Sound decision-making skills contributing to high levels of competence, confidence and credibility are required.
+ Cross-functional/cross-divisional experiences.
+ Experience dealing with international locations.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

To combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has division level influence and responsibility and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual will be actively called upon to influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.
**Main Responsibilities**
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
**Strategic Planning:**
+ Identify need for new regulatory policies, processes and SOPs and approve them.
+ Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture.
+ Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
+ Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
+ Develop global regulatory strategies and update based upon regulatory changes.
+ Anticipate emerging issues and develop solutions to them.
+ Develop solutions to address issues with other members of management and stakeholders.
+ Develop corporate positions on regulatory risk-benefit.
+ Create and develop product positioning strategies based upon regulatory requirements.
+ Integrate regulatory considerations into the corporation's global product entry and exit strategy.
+ Provide guidance for resource and development planning.
+ Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies Pre-market.
+ Communicate application progress to internal stakeholders.
+ Negotiate with regulatory authorities during the development and review process to ensure submission approval.
+ Provide strategic input and technical guidance on regulatory requirements to development teams.
+ Ensure pre-approval compliance activities are completed.
+ Formulate company procedures to respond to regulatory authority queries postmarked.
+ Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
+ Ensure a system is in place to manage access to information requests.
+ Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
+ Identify and present option for risk mitigation to decision makers.
+ Ensure adverse events are reported to regulatory agencies and internal stakeholders.
+ Manage processes involved with maintaining annual licenses, registrations, listings and patent information.
+ Ensure compliance with product post-marketing approval requirements.
+ Review and approve advertising and promotional items to ensure regulatory compliance.
**Job specific responsibilities may include**
+ Country-specific regulatory support, including the SEA market.
**Accountability**
+ Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies.
+ Must assure that all deadlines are met and provide effective leadership without direct authority.
+ Individual is recognized as a key opinion leader and resource in regulatory affairs.
**Influence/Leadership:**
+ Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation
+ Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives
+ Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units
+ May lead a project team or initiative within department or cross-functions/divisions
+ Provides technical leadership to business units
+ Exercises judgment independently
+ Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives
+ May participate / lead external industry working groups to influence advocacy in alignment with business strategies
**Planning/Organization:**
+ Creates mid- to long-range plans to carry out objectives established by top management
+ Develops and calculates a budget for one or more departments to meet organizational goals
+ Forecasts future departmental or group needs including human and material resources and capital expenditures
+ Determines and establishes organizational structure and supervisory relationships subject to top management approval
**Decision Making/Impact:**
+ Assignments are expressed in the form of objectives
+ Work is performed without appreciable direction
+ Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
+ Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity
**Requirements**
+ Bachelor's degree (or equivalent); bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
+ Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 12+ years' experience in a regulated industry (e.g., medical products, nutritional). 12+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
+ Regulatory history, guidelines, policies, standards, practices, requirements and precedents
+ Regulatory agency structure, processes and key personnel
+ Principles and requirements of applicable product laws
+ Submission/registration types and requirements
+ GxPs (GCPs, GLPs, GMPs)
+ Principles and requirements of promotion, advertising and labeling
+ International treaties and regional, national, local and territorial trade requirements, agreements and considerations
+ Domestic and international regulatory guidelines, policies and regulations
+ Ethical guidelines of the regulatory profession, clinical research and regulatory process.
+ Monitor costs of projects and of human and material resources within a department or unit
+ Monitor company-wide indicators such as market share and profitability
+ Develop least cost, least time means to provide optimal regulatory support for new products
+ Monitor external environment in area of technical or professional responsibility
+ Direct and manage the preparation of technical strategic regulatory documentation for agency submission
+ Communicate effectively verbally and in writing
+ Communicate with diverse audiences and personnel
+ Work with cross-functional teams
+ Work with people from various disciplines and cultures
+ Write and edit technical documents
+ Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
+ Negotiate internally and externally with regulatory agencies and participate in political lobbying
+ Plan and conduct meetings
+ Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
+ Effectively negotiate regulatory agreements with global regulatory agencies
+ Negotiate regulatory and scientific issues with management
+ Adjust presentation style and content to suit the audience
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Summary

Ensure that cosmetic products meet all applicable regulations. Collect and submit to the local authority documents required for licenses and renewals following strict deadlines. Follow up and set timelines for approvals. Protect Brands from any regulatory risk of non-compliance. Monitor existing and new regulations to anticipate any business impact. The role requires a proactive individual who can manage submissions, track progress, and communicate effectively with both regulatory authorities and internal stakeholders.

Responsibility

1. Regulatory Submissions:

• repare, coordinate, and submit regulatory dossiers/packaging data to the local authorities in Singapore.

• T ack submission progress and proactively address any queries or requests from the authorities.

• P ovide timely updates, monthly reports, and KPI reports on submission status to the Regulatory Affairs Manager in Singapore.

2. Documentation and Database Management:

• C mpile, organize, and maintain comprehensive regulatory documentation, including the source of product registration and approvals.

• Ensure that accurate and up-to-date regulatory information is maintained in relevant databases and systems.

3. C mpliance Support:

• M rketing claims: Maintain a current and accurate list of permitted and prohibited claims in accordance with local regulations. Review and ensure product claim compliance.

• L bel: Ensure that all product labels comply with local labelling regulations and requirements.

• I spection: Participate in local regulatory inspections, including preparation and follow-up activities.

• N n-compliance reporting: Immediately report any identified regulatory risks or instances of non-compliance.

4. Regulatory Monitoring:

• M nitor new regulations and guidelines relevant to the company's products.

• P ovide timely updates and summaries of regulatory changes to the Regulatory Affairs Manager and relevant stakeholders.

• A sess the potential impact of new regulations on the company's products and operations.

Reporting

• L cally: SEA Regulatory Manager

Knowledge & Attributes Required

• D ploma/degree with science background.

• 1 2 years of relevant working experience in regulatory affairs is preferred.

• E cellent time management skills with the ability to thrive in a fast-paced environment.

• A collaborative team player with strong interpersonal skills.

• M ticulous with high level of accuracy.

• E cellent communication skills, both written and verbal.