382 Compliance Ethics Professional jobs in Singapore

What to Expect

• Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
• Prepare and file global medical device applications and amendments, ensuring timely market access.
• Engage with regulatory authorities and distribution partnersto support product registrations
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
• Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
• Review and approve product labelingto ensure compliance with global regulatory requirements.
• Support and participate in inspections and auditsconducted by global regulatory authorities.

Requirements

• Minimum 5 years of Experience
• Fluent English

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 000 or email

Tagged as: Regulatory Affair

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1. Support product registration activities, including the preparation of registration dossiers, performance evaluation study design, and coordination with CROs (Clinical Research Organizations).
2. Act as the subject matter expert on medical device regulatory requirements, with a particular focus on FDA regulations. Stay current with relevant laws and ensure internal practices remain compliant.
3. Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA). Track submission progress and manage responses to queries or objections during the review process.
4. Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
5. Prepare and submit scientific and technical documentation for special projects or novel product classifications.
6. Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
7. Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
8. Undertake any additional regulatory tasks or projects as assigned by the management team.

1. A Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
2. Minimum 2 years of hands-on experience working with the FDA on medical device registration, submissions (e.g., 510(k), IDE), or related regulatory pathways.
3. Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
4. Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
5. Detail-oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.
6. Willing and able to travel to the United States for one month every six months as part of regulatory project and stakeholder engagement needs.

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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.

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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

Seniority level

• Seniority level Director

Employment type

• Employment type Full-time

Job function

• Job function Legal
• Industries Hospitals and Health Care

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Director P&B Regulatory Affairs Asia Pacific Director of Regulatory Affairs and Quality Senior Associate Director, Health, Public Policy and Communications JAPAC Strategic Planning & Operations Sr. Manager Regulatory Affairs Senior Regulatory Affairs Manager- Singapore - Remote Manager, Regulatory Affairs APAC (Excl CN & JP)

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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

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Job title: Regulatory Affairs Specialist
Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.

You will be reporting to the Regulatory Affairs Department in Japan.

【 Responsibilities 】
‐ Handle mainly regulatory operations tasks
- Report directly to the Regulatory Affairs Department in Japan
- Coordinate regulatory submissions (new and variation) across Asia/ASEAN
- Manage regulatory documents and ensure timely submissions
- Develop regulatory strategies with cross-functional teams
- Track and monitor local affiliate regulatory activities
- Identify and resolve regulatory issues proactively

【 What you will receive 】
- AWS
- Variable Bonus (Depends on Company and Individual performance)
- Annual Leave 14 days
- Medical Leave
- Medical Benefits
- Flexible Benefits (S$1500/year)
- WFH: Once a week to be at the Office, other days WFH

【Requirements & Preferences】
(Must)
- Diploma in any discipline.
- Minimum 2 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.
- Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.
- Proactive, self-motivated, and able to take initiative with high energy levels.

(Advantageous)
- Strong communication and negotiation skills.
- Logical thinking and sound problem-solving capabilities.
- Ability to adapt well to changes and work effectively under pressure.

---
We regret that only shortlisted candidates will be notified.

Registration No.: R24122864 (Cathy Chau )
Recruitment Licence: 12C5051

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Gene Solutions, a pioneer, rapidly growing and well-funded biotechnology company with cell-free DNA platform focusing on women’s health and oncology. We aim to transform the standard of healthcare in developing countries by making breakthrough genetic tests affordable and accessible to millions of people.

We have multiple openings for business development managers who will be working in South East Asian countries to serve our exponential growth.

Job Summary:

Lead and coordinate registration of international biotech certifications (CAP, FDA, HSA, NMPA, etc.) across APAC. Manage and collaborate with across relevant team/member to ensure timely and compliant registration.

Key Responsibilities:

· Develop and execute registration strategies for CAP, FDA, HSA, NMPA, and other international certifications within the APAC region.

· Manage end-to-end registration projects, including documentation, submission, and liaison with regulatory bodies.

· Be the primary contact person for the certificate registration, leading local certification processes and ensuring compliance with each country’s requirements.

· Work closely with local/international project team or on-site Regulatory leads to plan and align submission strategies.

· Coordinate with internal teams (Lab, QA, Operations, Legal,…) and external consultants for dossier preparation.

· Monitor regulatory changes, assess impact, and provide guidance for certification maintenance.

· Track project timelines and budgets; escalate deviations and propose mitigation plans.

· Provide progress updates and reports to senior management and stakeholders.

Job Requirements

· Bachelor’s degree in Biotechnology, Life Sciences, Pharmacy, or related field. Master’s preferred.

· 5+ years in biotech/pharma regulatory affairs, particularly with CAP/FDA/HSA/NMPA submissions in Asia.

· Proven track record in managing international certification projects and engaging with health authorities.

· In-depth knowledge of regulatory frameworks in at least one or two APAC countries.

· Excellent project management abilities, attention to detail, and organizational skills.

· Strong communication and collaboration skills across cross-functional teams and countries.

· Fluency in English. Additional regional languages (e.g., Mandarin) is a plus.

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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

**Job Description Summary**
- Support to the SG RA team in the preparation and uploading of UDI data in HSA portal.
- Assist in preparation for new product registrations and renewals by ensuring completeness in registrations dossiers.
- Collaborate on regional regulatory projects for Greater Asia.
- Maintain accurate records related to product registrations.
- Establish and maintain registration plans and registered product listings.
- Support with communications with external stakeholders such as government agencies, consultants, and distributors.
- Provide regulatory support to internal departments including Marketing, Quality Assurance, Technical Support, and Manufacturing
**Job Description**
**Work location: The Strategy Office**
**MAIN RESPONSIBILITIES:**
+ Support to the SG RA team in the preparation and uploading of UDI data in HSA portal.
+ Assist in preparation for new product registrations and renewals by ensuring completeness in registrations dossiers.
+ Collaborate on regional regulatory projects for Greater Asia.
+ Maintain accurate records related to product registrations.
+ Establish and maintain registration plans and registered product listings.
+ Support with communications with external stakeholders such as government agencies, consultants, and distributors.
+ Provide regulatory support to internal departments including Marketing, Quality Assurance, Technical Support, and Manufacturing.
**Job Requirements:**
+ Grad/Under Grad Bachelor's Degree in Science/Engineering related discipline;
+ Possess knowledge and understanding of UDI regulations in SG;
+ Good understanding of Medical Device Regulations and ISO standards;
+ Strong knowledge of Microsoft Office Suite (Word, Excel, PowerPoint);
+ Ability to work independently, and able to manage multiple priorities simultaneously
Required Skills
Optional Skills
.
**Primary Work Location**
SGP The Strategy
**Additional Locations**
**Work Shift**
SG Normal Office 0900-1800 (Singapore)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.