68 Regulatory Affairs Positions jobs in Singapore

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Participate in the development or implementation of clinical trial products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
• Provide responses to regulatory authority regarding product information or issues.
• Review all regulatory authorities' submission materials to ensure timeliness and accuracy.
• Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.

Coordinate product registration in designated countries by preparing dossiers and obtaining certificates within specified timeframes.

Act as a liaison between factories and regulatory teams of designated countries to ensure seamless collaboration.

Provide regulatory assessments for new products and change introductions to ensure compliance.

Offer expert advice on interpreting relevant guidance documents and standards to internal and external teams.

Support the preparation of tender submission documents to facilitate successful project implementations.

Perform other duties assigned by superiors to drive business growth and development.

• Bachelor's degree in a relevant field such as life sciences, chemistry, or engineering.
• A minimum of three years' experience in a relevant field with a proven track record of success.

This role offers opportunities for career advancement and professional growth in a dynamic industry.

Collaborate with experienced professionals to develop your skills and expertise.

Enjoy a comprehensive benefits package including health insurance, retirement plans, and paid time off.

We are a leading company in the industry, dedicated to delivering innovative solutions and exceptional customer service.

Our team is passionate about making a difference and strives to exceed expectations.

We value diversity, equity, and inclusion, and are committed to creating a workplace that reflects these principles.

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.

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

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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company's regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

1. A bachelor's degree in in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

A great opportunity to be part of a dynamic and progressive mid-size SME healthcare provider with a regional presence, as MD Pharmaceuticals Pte Ltd continues on its growth and expansion plans in Singapore, Malaysia, Hong Kong, Thailand, Myanmar and other parts of Asia in the coming years.

MD Pharmaceuticals Pte Ltd is now seeking to hire:

• Regulatory Affairs Pharmacist & Products Specialist (Pharmaceuticals products)

Unlike regular one-dimensional Pharmacist roles, the above position will enable the successful candidates to have more exposure to the related fields of Regulatory Affairs, Sales/Marketing & Business Development in the pharmaceutical industry.

The role is also based locally. However, there will be opportunities for overseas exposure and career advancement if the individual can prove himself /herself through solid work performance.

___

Main responsibilities:

• Assist with regulatory affairs and compliance work for the company's operations in Singapore and the Asian region, including dealing with product suppliers and regulatory bodies like HSA
• Actively stay updated and provide guidance on clinical information related to the company's suite of products, comprising both therapeutic drugs and healthcare supplements
• Drive the sales and marketing efforts of our products by gathering market/competitor information & proposing creative and feasible ideas as well as content to grow the sales and market share of our existing products
• Suggest and look into bringing in new potential products based on up-to-date market research and strong clinical evidence
• Gain a holistic understanding of the medical industry through practical sales and marketing outreach to develop the company's existing client base
• Establish sincere and professional relationships with healthcare professionals as well as key opinion leaders in the healthcare industry
• Assist with product trainings and provide related support to the Sales team
• Handle other duties as assigned

Key requirements:

• Must have at least a Bachelor's Degree in Pharmacy/Pharmacology, with a valid Pharmacist License registered under the Singapore Pharmacy Council
• Practical experience in the healthcare industry, including interaction with patients and healthcare professionals, would be beneficial
• Interested in Sales & Marketing/Business Development with an ability to apply clinical knowledge to better achieve sales and marketing outcomes
• Ability to work independently as well as in a team, including across different cultures and functions
• Solid communication skills, especially in both written and oral English. Working language proficiency in Mandarin/Thai would be an additional advantage for work-related translation purposes.
• Strong interpersonal skills, including ability to convince key stakeholders
• Positive, results-driven with a responsible attitude. Having own initiative is important for this role.
• Any Graphics Design skills, together with the knowledge of softwares such as Adobe Illustrator and Photoshop, etc. would be an advantage.

Interested candidates, please submit your updated resume & expected salary to us through the "Apply Now" button.

Job Description

Job Scope:

• Cosmetic Notification
• Documentation preparation: Assist in collecting, organizing product information and technical documents required for cosmetic notification.
• Regulatory submission: Support the submission of cosmetic product notifications to relevant regulatory authorities or online portals. Track and update submission status and follow up on pending applications.
• Database Management
• Maintain and update internal databases or trackers for product notifications, approvals, and related correspondence.
• Support Regulatory Compliance Checks
• Conduct first-line marketing claims review in accordance with the acceptable/prohibited claim list published by the authority.
• Cross-functional Coordination
• Liaise with Brand to gather required information related to product notification and marketing claim review.

Qualifications

• Undergraduate or recent graduate in Pharmacy, Chemistry, Life Sciences, or related field.
• Able to commit full time internship from Oct 2025 to Mar 2026
• Detail-oriented, organized, and able to manage multiple tasks.
• Proficient in Excel.
• Good communication skills (written and verbal).

Job Description

Job Scope:

Cosmetic Notification

• Documentation preparation: Assist in collecting, organizing product information and technical documents required for cosmetic notification.
• Regulatory submission: Support the submission of cosmetic product notifications to relevant regulatory authorities or online portals. Track and update submission status and follow up on pending applications.

Database Management

• Maintain and update internal databases or trackers for product notifications, approvals, and related correspondence.

Support Regulatory Compliance Checks

• Conduct first-line marketing claims review in accordance with the acceptable/prohibited claim list published by the authority.

Cross-functional Coordination

• Liaise with Brand to gather required information related to product notification and marketing claim review.

Qualifications

• Undergraduate or recent graduate in Pharmacy, Chemistry, Life Sciences, or related field.

• Able to commit full time internship from Oct 2025 to Mar 2026

• Detail-oriented, organized, and able to manage multiple tasks.

• Proficient in Excel.

• Good communication skills (written and verbal).

At LVMH, people make the difference in the art of crafting dreams.

Our people fuel our dynamic, entrepreneurial culture. We value collective ambitions, encouraging our talents to push boundaries and champion a curious, audacious state of mind. Our commitment to excellence is reflected in nurturing every individual with a growth mindset and development opportunities, consistently empowering them to reach their full potential. We are actively committed to positive impact through an inclusive environment that supports and gives back to our talented community.

Join us at LVMH, where your talent is at the heart of our collective successes.