64 Regulatory Affairs Manager jobs in Singapore

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee’s understanding and compliance with quality procedures and regulatory requirements.

About the company:

• American startup with senior management team; based in US, Europe and Singapore
• Hybrid work arrangement – 2 days in office, 3 days working from home
• Excellent medical insurance coverage
• Good variable bonus structure
• Great working culture
• Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at .

EA Personnel Registration No: R

We are seeking a highly organized Clinical Study Coordinator to support our team in managing clinical trials.

Key Responsibilities:

• Maintain accurate and up-to-date study files and documents in both physical and electronic formats.
• Assist with preparing study-related materials and training documents, ensuring timely delivery of high-quality results.
• Verify and track clinical trial data to ensure accuracy and completeness, identifying potential issues and proposing solutions.
• Prepare and organize documents for study reviews and monitoring visits, facilitating effective communication among team members.
• Coordinate with the study team, vendors, and clinical staff to ensure seamless execution of clinical trials.
• Receive and register clinical trial participants, adhering to strict protocols and guidelines.
• Process and prepare biological samples for testing and shipment, maintaining accurate records and logs.
• Manage inventory of study supplies and laboratory consumables, minimizing waste and optimizing resource allocation.
• Contribute to the maintenance and documentation of biomedical equipment and laboratory conditions, ensuring compliance with regulatory standards.

Requirements:

• Minimum GCE O Level and above
• Proficient in basic computer applications, particularly Microsoft Office

Attractive remuneration package includes competitive salary and benefits. We value diversity and encourage applicants from all backgrounds to apply. Please note that only shortlisted candidates will be notified.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mongkok, Kowloon, Hong Kong, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Seoul, Korea, Republic of, Singapore, Singapore, Taipei City, Taiwan

Job Description:

Johnson & Johnson is seeking a Manager, Regulatory Affairs to join the Regulatory Affairs APAC team.

The Manager, Regulatory Affairs is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.

The position, under minimal supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.

RESPONSIBILITIES:

Regulatory Strategy and Expertise

• Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
• Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
• Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs.
• Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals
• Provides input in post-registration activities, including labeling changes
• Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
• Maintains expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements
• Provides AP evaluation in licensing activities

Health Authority, Operating Companies, and Business Partner Interactions

Manages regulatory interactions with local operating companies and regional functions

• Serves as point of contact with local operating companies
• Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners.
• Interacts with local operating companies on individual products/processes
• Facilitates discussions with local operating companies on regional or global regulatory issues, as required
• Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assist operating company with these interactions.

Regulatory Submissions

• Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
• Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions
• Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance
• Reviews and provides input to critical submission documents
• Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines
• Participates in "Rapid Response Teams" to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.
• Ensures tracking of submission and approval milestones
• Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions

ADDITIONAL RESPONSIBILITIES:

• Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities and milestones
• Updates global regulatory staff regarding changes in regional regulatory requirements and provides support to VP, Regulatory Affairs AP as requested on initiatives.

REQUIRED TECHNICAL COMPETENCIES AND KNOWLEDGE:

Regulatory Strategy

• Good understanding of the pharmaceutical industry
• Detailed knowledge of local laws, regulations and guidance in the region related to full drug life cycle.
• Understanding of how laws, regulations and guidance apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment.
• Good understanding of and experience in drug development and/or marketed products.
• Ability to anticipate and influence regulatory developments in the region and assess business impact
• Ability to communicate AP regulatory strategy to global teams and assess impact on global/regional drug development
• Understanding of the scientific and medical principles applicable to the therapeutic area and specific products.
• Awareness of pricing and reimbursement issues in AP
• Understanding of how supply chain decisions impact registrations in AP

HA and Operating Company Interactions

• Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.
• Ability to work with and influence HA actions and outcomes.
• Project-related knowledge of commercial/medical business needs.
• Broad understanding of scientific data (CMC, clinical and non-clinical)
• Regulatory Input into Other Functions
• Comprehensive understanding of the needs of regional business partners.

Submissions

• Detailed knowledge of laws, regulations, and guidance as they apply to submissions in the region.
• Knowledge of what is needed for dossier components and submissions, how to obtain regional components and how long it will take to gather it. Understanding of documentation requirements.
• Ability to analyze reports to determine whether they meet regulatory requirements, and are consistent with the regional regulatory strategy.

Labeling

• Knowledge of local labeling requirements.
• Under minimal supervision, and supported by a supervisor, critically review labeling development/labeling revisions and assess impact on relevant countries
• Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling.
• Under minimal supervision, and supported by a supervisor, undertake labeling negotiations with health authorities

Decision Making and Problem–Solving

• Operates in a competitive, complex, and rapidly changing environment.
• Must make proposals and negotiate on prioritization and trade-offs on a project level.
• Independence on decision-making regarding regional product strategies with supervisor approval.
• Defines operational priorities and tactics in the region. Resolves conflicts in priorities in consultation with supervisor, regional business partners, and head office-based team members and other internal customers.
• Determines risk-management strategies for projects.
• Makes informed decisions by soliciting input from others where needed.
• Makes complex decisions in situations with multiple, ambiguous objectives and constraints.

Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these.

Independence/Autonomy

• Operates independently in a complex environment. Independent in daily activities, with /limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor. Position makes determination of routine work issues.

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:

• Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline.
• 6-10 years of overall experience in relevant pharmaceutical industry and preferably with regulatory experience
• Hands on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred. Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and /or Registration dossiers) also preferred.
• Demonstrated ability to handle multiple projects.
• Demonstrated organizational skills
• Ability to communicate to senior level management.
• Working knowledge of regulations in the region
• Experience in HAs interactions.
• Excellent verbal and written communication skills – proficiency in written and oral English and (Mandarin/Asian (Asia) languages is preferred.)
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required
• Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Proficient use of technology including MS office programs and Internet resources.
• Minimal regional business travel (1 or 2 times per year) may be required. Occasional international travel may be required.
• Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.

The Clinical Trials Manager is responsible for leading cross-functional teams to deliver global clinical trials. This involves collaborating with sponsors, managing timelines and project deliverables, and coordinating services contracted for the study.

• Project lead role for multiservice global clinical trials
• Interacting with sponsors and managing timeline and project deliverables
• Coordinating all services contracted for the study

• Bachelor's degree in a health-related field;
• At least two years of clinical trial management experience in Asia Pacific region ideally in a CRO environment;
• Experience in Infectious Disease/Ophthalmology/Neurology studies preferred;
• Excellent communication skills including good written and spoken English;
• Flexible, accountable, and comfortable working in a global environment.

Clinical Research Nurse

The successful candidate will be responsible for screening study participants according to regulatory guidelines and ethical standards.

• Conduct informed consent discussions and ensure participants understand the study's requirements.
• Monitor patient progress and collect data during clinical trials, ensuring accurate documentation.
• Administer study-related interventions as per protocol, including medications and treatments.
• Conduct assessments and follow-ups with participants, addressing any concerns and providing education.

Key Responsibilities Include:

• Screening and enrollment of patients in accordance with protocol.
• Collection of data from patients during their participation in studies.
• Monitoring of patients' responses to treatment and collection of relevant data.
• Assessment of patient safety and reporting of any adverse events or reactions.

• Diploma/Degree in Nursing
• Valid SNB & BCLS required
• Able to perform IV Cannulation and Phlebotomy

This role offers a unique opportunity to work on cutting-edge research projects while developing your clinical skills and knowledge.

We are seeking a Senior Project Management Specialist to oversee multi-site clinical trials from initiation to closure. The ideal candidate will collaborate with various stakeholders, ensuring seamless operations and compliance with regulatory requirements.

This role encompasses:

• Managing multi-site clinical trials
• Monitoring trial progress and guaranteeing timely funding and payment throughout the trial duration
• Liaising with vendors and drug companies for outsourced activities, clinical supplies, and issue resolution
• Reviewing and maintaining the trial master file
• Working closely with sites as the primary point of contact for operational activities

• Bachelor's degree in life sciences or a related field
• At least 4 years of clinical trial experience, including a minimum of 1 year of clinical trial management experience
• Required CRA experience
• Excellent time management skills and ability to handle multiple priorities independently

A highly motivated and detail-oriented Research Nurse is required to assist our team in various aspects of research projects. This role involves providing support to the research team, screening and recruiting suitable patients, briefing patients on research background, collecting data from medical records and research statistics, documenting adverse events, and performing phlebotomy when required.

• Assist in the conduct of clinical trials
• Screen and recruit suitable patients for research projects
• Brief patients on research background and obtain their consent
• Collect and document data from medical records and research statistics
• Perform phlebotomy and venepuncture when required

• Degree in Nursing, Life Sciences, Biomedical Sciences, or related field
• Valid SNB and BCLS certification
• Strong understanding of clinical research ethics and patient confidentiality
• Detail-oriented with good documentation and data entry skills

This is an excellent opportunity for a skilled Research Nurse to join our team and contribute to the success of our research projects.

The successful candidate will provide and coordinate nursing care to patients who participate in research studies, enforcing standards of care and professional codes of conduct.

This role requires a high level of expertise in clinical trials and the ability to ensure the safety and well-being of study subjects.

We are seeking an experienced and skilled nurse to join our team as a Senior Clinical Nurse in Research Specialization.

Join Our Team at the School of Biological Sciences, Nanyang Technological University, Singapore

The School of Biological Sciences (SBS), part of the College of Science, was established in 2002 with a mission to advance biological and biomedical sciences. At SBS, our research spans various areas, including infectious diseases, immunology, neurodegenerative diseases, telomere biology, and genome function. Over the years, SBS has attracted talented individuals from around the world and Singapore to join as scientific leaders and researchers.

For more details, please view

We are looking for a Project Officer to join the Yang Lab at NTU ( The successful candidate will contribute to an interdisciplinary project evaluating the clinical efficacy and biological mechanisms of traditional, complementary, and integrative medicine (TCIM) interventions for symptom management in cancer populations.

The role will focus on coordinating clinical trials and supporting laboratory operations, bridging patient-centered trial activities with bench-based biospecimen handling and multiomics investigations. Through this work, the candidate will be well-positioned to grow at the interface of clinical and laboratory science, while shaping a distinctive academic and professional trajectory.

Key Responsibilities:

• Coordinate randomized clinical trials, including ethics/IRB application and regulatory compliance
• Manage trial logistics, patient recruitment, scheduling, and follow-up
• Oversee collection, processing, and management of clinical data and biospecimens
• Conduct data entry, curation, quality control, and preliminary analyses
• Oversee laboratory operations, ensuring compliance with institutional and local safety regulations and good laboratory practices
• Manage procurement of equipment, reagents, and consumables
• Train and onboard new research staff and students
• Liaise with clinical collaborators, institutional partners, and external stakeholders
• Support project reporting and documentation for funding and administrative purposes

Job Requirements:

• Bachelor’s degree in life sciences, biomedical sciences, public health, social sciences, or related field
• At least 1-2 years of relevant experiences in clinical trial coordination, IRB submissions, or patient-facing research (entry-level candidates with strong interest are welcome to apply)
• Familiarity with biospecimen collection and handling, molecular biology, or omics techniques
• Good written and oral communication skills
• Proficiency in data management, statistical analysis, or clinical research sofeware
• Strong organizational and project management skills
• Excellent interpersonal skills to work both independently and collaboratively within a multidisciplinary team
• Demonstrated interest in integrative medicine, oncology, or translational research

The College of Science seeks a diverse and inclusive workforce and is committed to equality of opportunity. We welcome applications from all and recruit on the basis of merit, regardless of age, race, gender, religion, marital status and family responsibilities, or disability.

We regret to inform that only shortlisted candidates will be notified.