565 Regulatory Affairs Specialists jobs in Singapore

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Job Title : Regulatory Affairs Specialist

We are seeking a meticulous and proactiveRegulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes. This role will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist. The ideal candidate will be highly organized, possess strong analytical skills, and thrive in both independent and collaborative work environments.

Key Responsibilities & Duties:

1. Regulatory Compliance & Monitoring

• Maintain and update a centralized regulatory database to track product licenses, renewal deadlines, and compliance documents.
• Monitor regulatory updates from local country teams and assess their impact on business operations.
• Implement a tracking system to ensure timely renewals, submissions, and compliance with evolving regulations.
• Ensure proper implementation of global processes (e.g., labelling, document requests) and contribute to continuous improvement.
• Support by working with cross-functions to respond to customer audit purposes and regulatory agency queries.

1. License & Registration Management

• Oversee end-to-end product registrations, including dossier preparation, submission, and follow-up with regulatory agencies.
• Renew licenses for existing products, ensuring adherence to labeling, MRL (Maximum Residue Limits), and safety requirements.
• Liaise with internal teams (R&D, Quality, Legal) and external stakeholders (regulatory bodies, third-party consultants) to resolve compliance issues.
• Prepare and submit regulatory dossiers for locally manufactured dilution products (Singapore-specific).
• Coordinate with Singapore authorities (e.g., SFA, NEA) to secure necessary approvals.

3. Documentation & System Maintenance

• Upload and maintain registration certificates, technical documents, and compliance records in the Product Lifecycle Management (PLM) system.
• Ensure data accuracy and completeness for audit readiness and regulatory inspections.
• Generate reports for management on registration statuses, expirations, and pending actions.
• Maintain records of formulation changes, batch records, and compliance certifications.

1. Stakeholder Communication & Business Support

• Advise HQ, sales, and supply chain teams on regulatory considerations for:
• New product launches (e.g., registration pathways, labeling compliance)
• Product amendments (e.g., formulation changes, claims adjustments)
• Sharing of related information from local teams (eg. updated requirements for import/export from local teams).
• Respond to customer regulatory requests, including undesirable substances declarations, safety data sheets (SDS), and supplier compliance questionnaires.
• Prepare customized compliance statements for clients based on regional regulatory requirements.
• Hold monthly alignment calls with country regulatory teams and senior regulatory affairs executive to track registration progress and address challenges.
• Support sales and supply chain teams by providing regulatory guidance for product distribution and market access.

Qualifications & Skills:

Education & Experience:

• Bachelor’s/Master’s degree in Regulatory Affairs, Chemistry, Life Sciences, or a related field.
• 2-3 years of experience in regulatory affairs, preferably in agrochemicals, pharmaceuticals, or consumer goods.
• Experience with APAC regulatory frameworks (e.g., China, India, ASEAN) is a plus.

Technical Skills:

• Proficiency in regulatory databases (e.g., PLM, SAP) and MS Office (Excel, PowerPoint).
• Knowledge of GLP, GMP, and ISO standards for compliance documentation.

Soft Skills:

• Strong attention to detail – Ensures accuracy in submissions and compliance records.
• Proactive problem-solving – Anticipates regulatory hurdles and proposes solutions.
• Excellent communication – Clearly conveys complex regulations to non-experts.
• Collaborative mindset – Works effectively with cross-functional teams.
• Results-driven – Committed to meeting KPIs (e.g., on-time renewals, audit pass rates).
• Service-oriented – Supports internal teams with a solutions-focused approach.
• Long-term thinker – Aligns regulatory strategies with business growth.

Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.

We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.

• Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
• Advise on regulatory strategy, product classification, labeling, and compliance requirements.
• Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
• Support post-market surveillance activities.
• Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.

• Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
• Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
• Ability in speaking Chinese is a requirement.
• Strong organizational and project management skills; able to handle multiple submissions simultaneously.
• Familiarity with Therapeutic Products License (TPL) is preferred.

• Office-based role
• Monday – Friday, 9:00 am – 6:00 pm
• Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore

$4,100 – $5,300 monthly, based on experience

• Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
• Work closely with clients and regulatory authorities in a high-impact role.
• Gain exposure to ASEAN regulatory environments while building professional expertise.
• Join a specialist regulatory company offering career growth and professional development opportunities.

We are seeking a highly skilled and experienced Regulatory Manager to join our team in the Asia Pacific region. This is an exciting opportunity for a professional with a strong background in regulatory affairs to contribute to the success of our organization.

• Main liaison personnel with Head Quarters and all Partners on Regulatory matters for Asia Pacific countries
• Coordinate all queries, variations, submissions and registrations
• Handles product issues or complaints as well as quality issues
• Update of PDM (Product Data Management) records and Packaging records
• Maintain past dossiers and attend to queries relating to approved dossiers and dossier information
• Records of trademarks for APAC countries
• Maintenance of GTIN (Global Trade Item Number) information for products marketed in APAC countries
• Individual Case Safety Report (ICSR) monitoring, reporting & documentation for products marketed in Singapore
• Recall procedures, execution & documentation for products marketed in Singapore
• Coordination of recall procedures, execution & documentation for products marketed in APAC countries in accordance to local regulatory requirements
• Quarterly reporting of weekly literature screening outcomes
• Annual reconciliation of ICSRs (Individual Case Safety Report) for Singapore
• Coordinate with partners to reconcile the ICSRs for their respective countries
• Pharmacovigilance training
• Main Local Safety Officer (LSO) in liaison with Pharmacovigilance Department in HQ
• Submission of Product Quality Reports (PQRs) and Periodic Safety Update Reports in countries where it is legally required

• Degree in Pharmacy, Biology, Chemistry, or a related field
• 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products
• Good understanding of regional health regulations
• Strong attention to detail and organizational skills

This role offers a challenging and rewarding career opportunity for a motivated and experienced professional. If you have the necessary skills and qualifications, we encourage you to apply.

Please note that this job description is not an exhaustive list of duties and responsibilities, which may change over time.

We are seeking a highly motivated and organized Regulatory Affairs Specialist to fill this key role. The ideal candidate will have a strong attention to detail, excellent organizational skills, and the ability to work effectively in a fast-paced environment.

• Support submission of applications and variations for clinical trials and marketing authorisation across all pipelines
• Contribute to regulatory assessment of submission requirements based on relevant regulations
• Assist with administrative tasks necessary to support regulatory activities
• Review and provide input for regulatory documents
• Support additional duties as assigned

• Degree in Biological, Chemistry, or a related field
• No prior experience is required. An interest in Regulatory Affairs is essential
• A keen learner with a strong attention to detail and organisational skills is required
• Proficiency in English (written and spoken) is mandatory

This is an exciting opportunity for someone looking to develop their career in Regulatory Affairs.

• Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
• Advise on regulatory strategy, product classification, labelling, and compliance requirements.
• Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
• Support post-market surveillance activities.
• Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.

• Minimum 2-5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
• Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
• Ability in speaking Chinese is a requirement.
• Strong organizational and project management skills; able to handle multiple submissions simultaneously.
• Familiarity with Therapeutic Products License (TPL) is preferred.

• Office-based role
• Monday - Friday, 9:00 am - 6:00 pm
• Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore

• Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
• Work closely with clients and regulatory authorities in a high-impact role.
• Gain exposure to ASEAN regulatory environments while building professional expertise.
• Join a specialist regulatory company offering career growth and professional development opportunities.

Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.

We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.

• Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
• Advise on regulatory strategy, product classification, labeling, and compliance requirements.
• Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
• Support post-market surveillance activities.
• Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.

• Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
• Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
• Ability in speaking Chinese is a requirement.
• Strong organizational and project management skills; able to handle multiple submissions simultaneously.
• Familiarity with Therapeutic Products License (TPL) is preferred.

• Office-based role
• Monday – Friday, 9:00 am – 6:00 pm
• Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore

$4,100 – $5,300 monthly, based on experience

• Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
• Work closely with clients and regulatory authorities in a high-impact role.
• Gain exposure to ASEAN regulatory environments while building professional expertise.
• Join a specialist regulatory company offering career growth and professional development opportunities.

Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.

We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.

• Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
• Advise on regulatory strategy, product classification, labelling, and compliance requirements.
• Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
• Support post-market surveillance activities.
• Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.

• Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
• Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
• Ability in speaking Chinese is a requirement.
• Strong organizational and project management skills; able to handle multiple submissions simultaneously.
• Familiarity with Therapeutic Products License (TPL) is preferred.

• Office-based role
• Monday – Friday, 9:00 am – 6:00 pm
• Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore

$4,100 – $5,300 monthly, based on experience

• Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
• Work closely with clients and regulatory authorities in a high-impact role.
• Gain exposure to ASEAN regulatory environments while building professional expertise.
• Join a specialist regulatory company offering career growth and professional development opportunities.

We are seeking a skilled professional to fill the role of Regulatory Affairs Specialist. In this position, you will play a key part in ensuring product quality and compliance across multiple markets.

• Coordinate product registration processes across designated markets, ensuring timely submission of documentation and regulatory approvals.
• Serve as the primary liaison between internal teams and regulatory authorities to support compliance and market access.
• Provide regulatory assessments for new products and changes, advising teams on relevant standards and guidance.
• Support tender documentation, post-market surveillance, and complaint handling activities.
• Monitor regulatory updates, manage reporting of adverse events and recalls, and maintain compliance databases.
• Participate in audits, implement quality practices, and contribute to continuous improvement initiatives.

• A degree or equivalent qualification in engineering, life sciences, or a related field.
• Experience or knowledge of regulatory requirements within the healthcare/medical device/life-sciences industry.
• Strong problem-solving skills and attention to detail.
• Ability to manage multiple tasks and meet deadlines effectively.
• Excellent communication skills to liaise with internal teams and external authorities.
• Familiarity with quality management systems and audit processes.

• Play a key role in shaping compliance strategies across multiple markets, ensuring product safety and timely market access.
• Work closely with global teams and regulatory bodies, gaining exposure to diverse healthcare systems and international standards.
• Contribute to improving patient outcomes through high-quality medical technologies, while advancing your expertise in regulatory and quality excellence.

• Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
• Advise on regulatory strategy, product classification, labelling, and compliance requirements.
• Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
• Support post-market surveillance activities.
• Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.

• Minimum 2-5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
• Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
• Ability in speaking Chinese is a requirement.
• Strong organizational and project management skills; able to handle multiple submissions simultaneously.
• Familiarity with Therapeutic Products License (TPL) is preferred.

• Office-based role
• Monday - Friday, 9:00 am - 6:00 pm
• Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore

• Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
• Work closely with clients and regulatory authorities in a high-impact role.
• Gain exposure to ASEAN regulatory environments while building professional expertise.
• Join a specialist regulatory company offering career growth and professional development opportunities.