427 Regulatory Affairs Specialists jobs in Singapore

Job Overview

We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our team in Singapore. The successful candidate will be responsible for ensuring compliance with regulatory guidelines and policies, as well as supporting the implementation of our Quality Management System.

Key Responsibilities:

• Regulatory Affairs:
• Ensure understanding and adherence to relevant regulations, policies, and procedures related to our business activities and products.
• Maintain product and company compliance with regulations for maintenance of approvals.
• Manage ISO and GMDP records, and work closely with the ISO/GMDP team to provide timely updates on company regulatory and licensing matters.
• Prepare and submit regulatory applications, including creating and maintaining templates and ensuring completion of submissions.
• Advise management on regulatory processes, compliance, and updates to policies.
• Maintain regulatory documentation databases.
• Develop and maintain communication with regulatory agencies regarding submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews quality management system for new product(s) launch in local and/or regional markets.
• Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers' requirements.
• Support country managers in medical device regulations or other regulations for regional countries.
• Quality Management System:
• Support the Management Representative in the company quality management system.
• Maintain and update the document control system to ensure all quality-related documents are easily accessible, properly categorized, and up-to-date.
• Oversee the implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO 9001, GMDP, and other relevant standards.
• Review and update ISO 9001 & GMDP documents when necessary and maintain records.
• Review and ensure all documents, including SOPs, work instructions, manuals, and forms, meet regulatory and company standards.
• Handle quality-related matters such as non-conformances, customer complaints, change notifications.
• Handle customer or supplier-related enquiries, questionnaires, etc.
• Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner.
• Follow-up and verify corrective/preventive action (CAPA) effectiveness.
• Provide ISO 9001 and GMDP orientation to new employees.
• Compliance:
• Coordinate, schedule, and conduct required compliance orientation and training for employees.
• Responsible for ensuring compliance to regulations related to export controls and maintain records.
• Provide support to employees on regulatory requirements and compliance procedures.
• Serve as a BizSafe member by overseeing and coordinating the preparation, management, and maintenance of all risk management and related documentation. Ensure all required documents are completed, up-to-date, and in compliance with BizSafe standards and regulations.

Requirements:

Candidates should bring with them:

• A degree in Life Sciences, Biomedical, or any other related discipline.
• Minimum 2 years' experience in performing a similar job scope.
• Relevant experience in regulatory affairs will be advantageous.
• Good knowledge and application of Microsoft 365.
• Able to work under a matrix reporting structure.
• Good organizational and time management skills.
• A strong database experience (Access, Excel) to set up functions, enter data or process information.
• Excellent interpersonal, presentation, and verbal/written communications skills.
• Meticulous, able to work independently and timely in meeting deadlines.
• Integrity with a history of ethical decision-making is essential.
• Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
• Knowledge in GDPMD, ISO 9001, IVDR preferred.
• Familiarity with Health Science Authority's regulatory on medical devices, product registration, field safety correction, and licensing requirements.

Regulatory Affairs Specialist

1 year contract, with potential to renew

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Company Description:

Our client is an American consumer health company. It is the proprietor of well-known consumer brands. They combine the power of science with meaningful human insights to empower people around the world to live healthier lives.

Summary:

Manage the regulatory activities for cosmetic products, drugs and other consumer health products, upholding both internal and external quality and compliance standards.

Key Duties & Responsibilities:

• Responsible to manage the documentation, compilation, preparation and submission of dossiers for regulatory as per Singapore requirement.
• Ensure timely submission and responsible to monitor the status with tight follow up.
• Review of products label/artwork and advertisement materials to ensure compliance to the local requirement.
• Requests, organizes, and prepares dossier documentation and related fillings to regulatory agencies under planned and approval timeline.
• Work collaboratively with internal stakeholders to deliver timely and commercially advantageous approvals and uphold regulatory compliance and marketing continuity.
• Updating product registry in all relevant internal systems and trackers.
• Assist to research on regulatory related information or updates, compile and presented to RA Manager and Senior Specialist whenever required.
• Support RA Manager with any other task as and when required

Requirements

• Degree in any Science field, with minimum 1 year of related experience
• Proficient in Microsoft Office

Interested parties, kindly click on the apply button.

Alternatively, you can share your CV at

EA License: 94C3609

Reg No: R1440247

Principal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC's compliance policies and ensure full adherence where necessary.

1. Regulatory Affairs

• Understand relevant regulatory regulations, policies & procedures behind the company's business activities and products
• Ensure product and company's compliance with regulations for maintenance of approvals
• Maintain ISO and GDPMDS records, and work closely with the ISO/GDPMDS team to provide timely updates on company's regulatory and licensing matters
• Preparation and submission of regulatory applications, including creating and maintaining templates and ensuring completion of submissions
• Advise management on regulatory processes, compliance and updates to policies
• Responsible for the maintenance of regulatory documentation databases
• Develop and maintain communication with regulatory agencies regarding submission strategies, compliancetest requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews quality management systemo new product(s) launch in local and/or regional markets
• Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers' requirements.
• Support the country managers in medical device regulations or other regulations for regional countries
• Liaise with related departments in the PHC Group

2. Quality Management System

• Support the Management Representative in the company quality management system
• Maintain and update the document control system to ensure all quality-related documents are easily accessible, properly categorized, and up to date.
• Oversee the implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO9001, GDPMDS and other relevant standards.
• Review and update ISO 9001 & GDPMDS documents when necessary and maintain records.
• Review and ensure all documents, including SOPs, work instructions, manuals, and forms, meet regulatory and company standards.
• Handle quality related matters such as non-conformances, customer complaints, change notification.
• Handle customer or supplier related enquiries, questionnaire and etc.
• Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
• Follow-up and verify corrective/preventive action (CAPA) effectiveness.
• Provide ISO 9001 and GDPMDS orientation to new employees

3. Compliance

• Coordinate, schedule and conduct required compliance orientation and training for employees
• Responsible to ensure compliance to regulations related to export controls and maintain records
• Provide support to employees on regulatory requirement and compliance procedures.
• Serve as a BizSafe member by overseeing and coordinating the preparation, management, and maintenance of all risk management and related documentation. Ensure all required documents are completed, up-to-date, and in compliance with BizSafe standards and regulations.

REQUIREMENTS

Candidates should bring with them

• A Degree in Life Sciences, Biomedical or any other related discipline.
• Minimum 2 years' experience in performing a similar job scope.
• Relevant experience in regulatory affairs will be advantageous
• Good knowledge and application of Microsoft 365.
• Able to work under a matrix reporting structure.
• Good organizational and time management skills.
• A strong database experience (Access, Excel) to set up functions, enter data or process information.
• Excellent interpersonal, presentation and verbal/written communications skills.
• Meticulous, able to work independently and timely in meeting deadlines.
• Integrity with a history of ethical decision-making is essential
• Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
• Knowledge in GDPMD, ISO9001, IVDR preferred.
• Familiarity with Health Science Authority's regulatory on medical devices, product registration, field safety correction and licensing requirements.

We are looking for a highly motivated and detail-oriented individual to join our consulting company as a Regulatory Affairs Specialist . Your primary responsibility will be to ensure compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.

1. Manage submission and approval processes for applications such as Manufacturing License Application (MLA), Technical/Site Transfer Applications, and Marketing Authorization Applications.
2. Prepare and submit documentation for post-approval applications and ensure compliance with regulatory processes during internal and external audits.
3. Stay updated on national, European, and international guidelines/legislation, ensuring compliance within assigned regions.
4. Act as a liaison between the pharmaceutical company and regulatory agencies.
5. Support internal requests for information and work on lifecycle maintenance activities.

• 5-8 years of relevant international experience in Regulatory Affairs.
• Expertise in MLA, MAA, CTD, Variations, Renewals, and Labeling Applications.
• Experience working with European Regulatory Authorities.
• Familiarity with software such as Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat.
• Strong organizational and communication skills.
• Ability to prioritize tasks effectively.
• Experience in people management/coordination and promotional/non-promotional activities is a plus.

• Knowledge of US FDA and EU regulations, including Labeling, CMC, and electronic submission standards.
• Proficiency in document management systems, data analysis, and negotiation.
• Excellent presentation and analytical skills.

If you are passionate about regulatory affairs and eager to make a significant impact, we encourage you to apply for this exciting opportunity.

At Gnosis by Lesaffre, we harness the power of microorganisms to transform compounds into usable nutritional actives, probiotics, and nutritional and functional yeasts that benefit human wellbeing. We strive to create a world that moves better, digests better, ages better, feels better, and ultimately, lives better thanks to microorganisms and biotransformation.

Overview

At Gnosis by Lesaffre APAC, we are looking for a talented, dynamic, and motivated Regulatory Affairs Specialist to support the expansion of our business in APAC. Reporting to the APAC Senior Regulatory Affairs Manager, you will be responsible for the regulatory compliance of our product portfolio and play a critical role providing strategic advice on regulatory risks and opportunities to support market growth and innovation in APAC.

Responsibilities

1. Ensure compliance of assigned Gnosis’ product portfolio with local regulations.
2. Manage timely regional registration activities, including registration dossier preparation and proper documentation of submitted documents.
3. Execute regional regulatory strategies in line with the global strategic plan.
4. Provide regulatory guidance and advice to internal stakeholders (e.g. marketing, R&D).
5. Conduct regulatory watch and monitor changes in local legislation landscape, assess the impact towards Gnosis’s product portfolio and communicate accordingly to internal stakeholders.
6. Build effective working relationships with internal stakeholders.
7. Work closely with regulatory colleagues to maintain knowledge in APAC countries and product-specific regulatory requirements.
8. Maintain full awareness of regulatory activities of assigned portfolio and provide regular reports.

Qualifications

1. Knowledge in food/food supplements across APAC, experience in Korean food regulations is a plus.
2. Good organizational skills, possess structured approach to working tasks.
3. Collaborative team player with the ability to work independently.
4. Experience in project management appreciated, however project management course will be offered.
5. Comfortable working in an international fast-paced environment.
6. Good written and verbal communication skills.
7. Fluent in English, Korean is a plus.

Education and experience

1. Bachelor’s degree or equivalent in Science, Pharmacy or related scientific discipline.
2. Minimum of 2 years of regulatory experience in healthcare or food industry.

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

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.

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.
  
  

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

• 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.
  
  

• 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
  
  

• 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
  
  

• 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
  
  

• 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 Director

• Employment type Full-time

• Job function Legal
• Industries Hospitals and Health Care

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