138 Healthcare Regulations 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 658066

$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.

The Regulatory Affairs Executive in Pharmaceuticals based in New Delhi, India, will report to the Head of Regulatory Affairs / Managing Director. You will be responsible for managing the preparation and submission of regulatory documentation to health authorities to support the development, approval, and maintenance of pharmaceutical products. Your role will ensure compliance with national and international regulatory requirements throughout the product lifecycle.

Your key responsibilities will include:

• Approving labels, packaging, and promotional materials for compliance
• Summarizing scientific data
• Preparing regulatory dossiers for new product approvals, renewals, and variations
• Ensuring timely submissions to regulatory agencies
• Managing communication with health authorities
• Tracking regulatory changes
• Reviewing product materials for compliance
• Supporting clinical trials
• Maintaining regulatory databases
• Collaborating with cross-functional teams

To qualify, you should hold a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field, along with 4-5 years of experience in pharmaceutical regulatory affairs. Strong knowledge of global regulatory requirements from FDA, EMA, ICH, CDSCO, etc., attention to detail, critical thinking, organizational skills, and excellent communication skills are essential.

Preferred qualifications include Regulatory Affairs Certification (RAC) or equivalent, familiarity with global submission platforms, and experience in new drug applications and post-marketing surveillance.

This is a full-time position offering benefits such as cell phone reimbursement, day shift schedule, and a performance bonus. If qualified and interested in contributing to regulatory strategies during drug development and post-marketing phases, we encourage you to apply.

For inquiries, please contact Tanveer Kaur, HR, at +91 97hidden_mobile 3.

• Salary Range MYR 7,000 - 7,999
• City Bandar Sri Damansara
• Country Malaysia

• 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.
  

• 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.
  

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: R2197665

#LI-JACSG

#countrysingapore

About Soleil Collective

Backed by Gauge Capital, Soleil Collective is building a portfolio of leading high-growth brands specializing in sunless tan, suncare, and bodycare products. Soleil accelerates growth and improves profitability with sales, marketing, operations, and strategic management expertise. We have completed two acquisitions to date: Loving Tan and Coco & Eve.

Loving Tan is the category leader in prestige tanning, delivering the most natural-looking tan. Proudly made on Australia’s Gold Coast, the professional quality, natural olive color, and flawless application are beloved by A-listers, creators, and beauty lovers alike. Coco & Eve’s story starts in Bali, among volcanic beaches and lush rainforests. The brand offers sun-kissed, skin-loving tan products and deliciously scented, efficacious haircare formulated with tropical Balinese ingredients.

Responsibilities

Product Compliance

• Work with Brand and Product Development to ensure compliance of all new and existing products with global legislative requirements (FDA, EC, HSA, etc.).
• Complete registration of all new products/categories not covered by external regulatory partners.
• Liaise with regulatory agencies and manufacturers to resolve compliance issues and suggest corrective measures.
• Assist in substantiating product claims through research and provide evidence to Marketing and Brand teams.
• Support Product teams in quality-related matters, ensuring adherence to international standards and overall product compliance.

Business Development Compliance

• Provide guidance on regulatory requirements for entering new markets and channels.
• Evaluate compliance submissions from new retailers and act as the main contact until registration is complete.

Vendor Management

• Support the Operations Director in screening new suppliers and conducting due diligence.
• Define minimum factory compliance requirements (CSR), ensure conformity, and lead sustainability improvement initiatives.
• Coordinate with Legal and Quality teams to communicate requirements to trading partners and manufacturers.
• Collaborate with regulatory partners to develop a global compliance matrix for Soleil Collective’s current and future product categories and markets.

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.

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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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