60 Healthcare Regulations jobs in Singapore

WILHELM HAUFFMANN & COMPANY PTE. LTD.

Wilhelm Hauffmann is wholly owned subsidiary of Borden Eagle Singapore Pte. Ltd. for Eagle Brand consumer healthcare products ( and its associated brands.

The company main activities are in research and development (R&D) of consumer healthcare products, intellectual property (IP) holder (trademarks, patents and formularies), regulatory affairs (RA), technical compliance and business development in licensing the IP.

In view of the business expansion, we are looking for associate/senior associate who has RA/NPD experience to join our team :

Roles & Responsibilities

· Assist to work along with internal and external units towards achieving common strategic regulatory goals.

· Provide support in regulatory affairs (RA) for product registration, variations and renewal submissions (consumer health care products e.g. OTC/generics, health supplements, cosmetics and medical device). Maintain and track the registration status of all marketed products in compliance with relevant regulations.

· Liaise with cross-functional teams including Marketing, Quality and R&D to ensure regulatory compliance across product lifecycle activities such as artwork and labeling, claims substantiation, health authority queries, new product development, and change controls.

· Stay informed of evolving regulatory requirements; assess and communicate their impact and support the supervisor in driving necessary actions to maintain compliance.

· Provide technical support and work closely with the relevant stakeholders (internal, external) on change management of raw materials/packaging materials as well as new product development (NPD) process.

· Work with the business units on NPD requirement, review and evaluate together with the technical team from manufacturing operations on the product concept/formulation/data analysis.

· Maintain a systematic archive of marketing materials (advertisements, social media posts, POSM, packaging artworks, digital and print campaigns) for each market and product.

· Ad-hoc projects and tasks assigned by the management.

Requirements

· Possess a good degree in pharmacy, life sciences/applied chemistry or equivalent from established university.

· At least 2 years of product registration experience preferably in the pharmaceutical line, consumer healthcare products or related industry.

· Knowledge of regulatory procedures & guidelines in Asia Pacific countries / US FDA / EMA / ICH / PIC/S framework are preferred. Additional knowledge or experience in brand management, marketing compliance, or claims substantiation is an advantage.

· Good documentation and project management skill.

· Communicate openly with all stakeholders, embrace diversity of thoughts, create trustful relationships, lead and collaborate with willingness, fairness and integrity.

· Familiar with risk management tools/principles.

· Some exposure in product innovation/NPD and/or legal agreement matter is an advantage.

· Other core competencies i.e. good interpersonal skills, effective influencing, decision making and problem solving skills, time management and result-driven.

Job Responsibilities
Implement strategies for regulatory approval and ensuring compliance with regional and international regulations for all product categories of the company.
Develop a comprehensive understanding and maintain current knowledge of the regional and international regulations and standards applicable to the company products.
Co‐ordinate, prepare, submit and follow up registration applications to regional authorities within the stipulated timeline, and to high standards, to ensure that market permissions are obtained and maintained in line with the company’s plans.
Liaise with suppliers/contract manufacturers for documents required for product registration and other related regulatory matters.
Ensure timely registration or license renewal of products and that submissions meet strict deadlines.
Maintain and update requirements for labelling and consolidated standards of regulatory safety limits applicable to the company products.
Review labelling, summary of product characteristics and marketing material to ensure compliance with current legislation and registered particulars and take action.
Maintain and implement the product artwork and label management system.
Maintain an internal finished product and ingredient database.
Keep up to date with changes in regulatory legislation, guidelines and best practices, provide updates and assess the impact of these changes on the products or the company.
Implement and update standard procedures for, monitor and ensure timely completion of reactions to regulatory requirement changes.
Foster collaborative, efficient and effective working relations, liaise and negotiate with regulatory authorities such as the HSA, SFA, regulatory agencies and industrial associations.
Give regulatory advice, develop and maintain links to other teams (including product, quality, supply chain, logistics, marketing, design) so that appropriate development, quality or marketing plans may be established.
Ensure best practice for filing/archiving of relevant product correspondence; create and update Product Information Files to high standards.
Requirements
Degree in science, preferably in chemistry, biochemistry, pharmacy, biomedical science, cosmetic science or similar
Proven relevant experience within the regulatory environment
Proven familiarity and experience in the cosmetic, health food, dietary supplement, pharmaceutical or other FMCG industry
Experience in ASEAN TMHS and/or cosmetic regulations, including PIF handling, is preferred
Self‐starter, good at working well independently with initiatives
Meticulous & detail‐oriented
Planning & organising skills; time management skills
Communication & negotiation skills
Analytical & problem‐solving skills
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Responsibilities
Support development and execution of regulatory strategies aligned with Haw Par’s strategic priorities.
Prepare regulatory dossiers for new registrations, variations and renewal submissions to authorities in compliance with current regulatory requirements.
Collaborate with cross-functional teams including Marketing, Quality, R&D and subsidiary sites’ RA team, and external stakeholders to ensure regulatory compliance across product lifecycle activities such as artwork and labeling, claims substantiation, health authority queries, new product development, and change controls.
Monitor and report submission statuses in real time using the RA department’s project management tools; proactively follow up, anticipate potential issues, and implement solutions (in consultation with supervisor) to ensure timely approvals.
Communicate regulatory approvals promptly to cross-functional teams and ensure accurate documentation of approval records in regulatory databases and repositories.
Stay informed of evolving regulatory requirements; assess and communicate their impact and support the supervisor in driving necessary actions to maintain compliance.
Qualifications
Bachelor’s degree in Pharmacy, Chemistry or Lifesciences.
Minimum 2 years of relevant experience in a regulated environment, preferably in OTC, cosmetics, or consumer health products.
Familiarity with ASEAN/EU and ICH regulatory guidelines.
Experience with European cosmetics and herbal products is an advantage.
Detail-oriented and proactive, with strong analytical skills and excellent written and verbal communication abilities.
A collaborative team player with strong interpersonal skills; able to manage multiple tasks and projects simultaneously with effective time management.
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Salary Range MYR 7,000 - 7,999
City Bandar Sri Damansara
Country Malaysia
Job Description
Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
Ensure compliance with advertisement and labeling regulations in each marketing territory.
Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
Plan and lead the implementation of internal RA audits on an annual basis.
Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
Support regulatory matters related to custom import requirements and documentation.
Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
Requirements
Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers,effectively.
In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
Meticulous and detail-oriented, capable of working independently with minimal supervision.
Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
Pharmacist background with a valid license will be an added advantage.
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Overview
Welcome diversity and apply as you are!
At Adisseo, we cherish the value of diversity whatever it may be.
By joining Adisseo , you will join committed people who make the difference every day to contribute to this challenge.
By joining Adisseo , you will integrate a dynamic international environment.
By joining Adisseo , you will discover a world full of opportunities for every stage of your career by being actor to your professional journey.
Job Title : Regulatory Affairs Specialist
We are seeking a meticulous and proactive Regulatory 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.
Responsibilities
Key Responsibilities & Duties:
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.
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.
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
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.
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Job Title:
Regulatory Affairs Specialist
Location:
Singapore
About Us:
The company is a global pharmaceutical company with significant presence in Asia, with operations in multiple countries.
Key Responsibilities:
Formulation of pharmaceutical strategies in collaboration with other teams and departments
Monitoring and tracking of pharmaceutical operations at each local company
Qualifications:
2-3+ years of experience in pharmaceutical business
Proactive, high level of initiative, communication/negotiation skills, logical thinking
Interested applicant, please click APPLY NOW
Do note that we will only be in touch if your application is shortlisted.
Peh Yong Sin
JAC Recruitment Pte Ltd
EA License Number: 90C3026
EA Personnel: R
#LI-JACSG
#countrysingapore
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About ResMed
At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.
Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.
Team Overview
Regulatory Product Strategy & Delivery (RPSD) (Singapore).
The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer. The team supports New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects, enabling global submission readiness, risk assessments, and regional collaboration.
As an individual contributor in this team, the Specialist, Regulatory Product Strategy & Delivery – Singapore will partner with cross-functional stakeholders to ensure design, documentation, and change activities meet regulatory expectations across all key markets (e.g., US, EU, APAC, LATAM)
Position Summary
As a Specialist, Regulatory Product Strategy & Delivery – Singapore, you will contribute directly to the successful delivery of regulatory strategy, submission documentation, and change management activities for Singapore-manufactured devices and accessories.
You will represent Regulatory Affairs on cross-functional teams and collaborate with global RA colleagues to ensure alignment, accuracy, and traceability across submissions and product lifecycle updates. This is a critical role in ensuring regulatory quality, efficiency, and global market continuity.
Key Responsibilities
Regulatory Strategy & Execution
Support regulatory strategy development and documentation for NPI and PLE projects led by the Singapore RPSD team.
Participate in the preparation, review, and submission of global regulatory filings including 510(k), CE MDR, TGA, Health Canada, and regional registrations.
Contribute to authoring of submission content such as labelling justifications, equivalence arguments, standards declarations, and technical summaries.
Product Change Support
Evaluate the regulatory impact of product and design changes via DCA/CPA frameworks, contributing to global significance assessments and risk mitigation actions.
Review and update technical file documentation, declarations, and certificates in collaboration with the Regulatory Foundations team.
Track submission timelines and deliverables using Jira and other RA platforms.
Cross-Functional Collaboration
Represent Regulatory Affairs in cross-functional project teams involving engineering, clinical, quality, labelling, and supply chain.
Participate in design reviews, change assessments, and internal risk forums as the RA contributor for Singapore-based products.
Collaborate with Regional RA and global RPSD counterparts to ensure harmonization of documentation and submission approaches.
Regulatory Systems & Process Improvement
Maintain accurate regulatory records and document control through RIMSYS, Confluence, and SharePoint tools.
Support continuous improvement activities by contributing to template updates, process harmonization, and RA onboarding content.
Assist in audit readiness activities and postmarket traceability tasks as needed.
Other Duties and Requirements
Perform additional responsibilities as required to support RA and RPSD objectives.
Contribute to process improvements and special projects across Regulatory Affairs.
Support inspections, audits, and team collaboration activities.
Qualifications & Experience
Required
Bachelor’s degree in engineering, life sciences, health policy, or a related field.
3+ years of experience in Regulatory Affairs or a compliance-related role within a regulated industry (preferably medical devices).
Familiarity with product development under design control and regulatory frameworks (e.g., ISO 13485, ISO 14971, 21 CFR 820).
Strong communication, organization, and document review skills.
Ability to manage multiple priorities, meet deadlines, and operate effectively in a cross-functional team environment.
Preferred
Experience preparing or contributing to global regulatory submissions (e.g., FDA 510(k), EU MDR, TGA).
Understanding of Singapore-specific regulatory frameworks and product license processes.
Familiarity with submission and documentation tools such as Jira, RIMSYS, and Confluence.
Experience supporting Class II or III medical devices in respiratory or digital health fields.
Who You Are
You are a regulatory problem-solver and proactive collaborator. You bring technical curiosity and process discipline to your work, with a sharp eye for detail and a strong sense of responsibility for quality. Whether it’s preparing documentation, clarifying regulatory pathways, or contributing to design decisions—you show up with clarity, consistency, and a drive to improve.
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
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Company Description
Poli Medical Company Pte Ltd, founded in 1971, began as a patent medicine manufacturer specializing in chinese pharmaceuticals and health supplements. Over the years, it has expanded to offer contract manufacturing/OEM services of private label health and food/health supplements and marketing/distribution of related products. Today, Poli Medical operates one of the few pharmaceutical manufacturing facilities in Singapore certified by the Health Authority of Singapore (HSA) with GMP standards. The company offers over 200 SKUs, with around 100 registered with local authorities, and its products are available in countries including most of south east asia, Europe and the United States.
Role Description
This is a full-time hybrid role for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for preparing regulatory documentation, ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining updated knowledge of regulatory affairs. The role involves working from home part-time and is located in Singapore.
Qualifications
Experience in Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements
Knowledge and experience in Regulatory Affairs and Regulatory Submissions
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Attention to detail and ability to work independently
Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, or Chemistry
Experience in the pharmaceutical industry is a plus
Seniority level
Entry level
Employment type
Full-time
Job function
Legal
Pharmaceutical Manufacturing
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Job Responsibilities

• Implement strategies for regulatory approval and ensuring compliance with regional and international regulations for all product categories of the company.
• Develop a comprehensive understanding and maintain current knowledge of the regional and international regulations and standards applicable to the company products.
• Co-ordinate, prepare, submit and follow up registration applications to regional authorities within the stipulated timeline, and to high standards, to ensure that market permissions are obtained and maintained in line with the company’s plans.
• Liaise with suppliers/contract manufacturers for documents required for product registration and other related regulatory matters.
• Ensure timely registration or license renewal of products and that submissions meet strict deadlines.
• Maintain and update requirements for labelling and consolidated standards of regulatory safety limits applicable to the company products.
• Review labelling, summary of product characteristics and marketing material to ensure compliance with current legislation and registered particulars and take action.
• Maintain and implement the product artwork and label management system.
• Maintain an internal finished product and ingredient database.
• Keep up to date with changes in regulatory legislation, guidelines and best practices, provide updates and assess the impact of these changes on the products or the company.
• Implement and update standard procedures for, monitor and ensure timely completion of reactions to regulatory requirement changes.
• Foster collaborative, efficient and effective working relations, liaise and negotiate with regulatory authorities such as the HSA, SFA, regulatory agencies and industrial associations.
• Give regulatory advice, develop and maintain links to other teams (including product, quality, supply chain, logistics, marketing, design) so that appropriate development, quality or marketing plans may be established.
• Ensure best practice for filing/ archiving of relevant product correspondence; create and update Product Information Files to high standards.

Requirements

• Degree in science, preferably in chemistry, biochemistry, pharmacy, biomedical science, cosmetic science or similar
• Proven relevant experience within the regulatory environment
• Proven familiarity and experience in the cosmetic, health food, dietary supplement, pharmaceuticalor other FMCG industry
• Experience in ASEAN TMHS and/or cosmetic regulations, including PIF handling, is preferred
• Self-starter, good at working well independently with initiatives
• Meticulous & detail-oriented
• Planning & organising skills; time management skills
• Communication & negotiation skills
• Analytical & problem-solving skills