45 Regulatory Affairs Professionals 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

Your new company

Join our client to be part of their international team as a Regional Regulatory Affairs Specialist, where your expertise in APAC regulations and cross-functional collaboration will drive impactful healthcare solutions across diverse markets.

Your new role

You will be instrumental in managing regulatory operations across international markets. Based in Singapore, you will work closely with local affiliates and their designated Responsible Persons to ensure the timely and compliant execution of product registrations, renewals, and post-approval changes. Your role will involve preparing and overseeing regulatory documentation—including ASEAN CTD and eCTD formats—while ensuring alignment with evolving regional requirements. You will also maintain accurate records using electronic submission systems and tracking tools. In addition, you will collaborate with cross-functional teams such as CMC, Support & Promotion, Labelling, Business, Quality Assurance, and Pharmacovigilance to ensure regulatory alignment and contribute to strategic planning through regulatory intelligence and competitor insights.

What you'll need to succeed

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline.
• Minimum of 3 years of hands-on experience in regulatory affairs within the pharmaceutical industry, ideally with regional exposure across APAC markets.
• Solid understanding of APAC regulatory frameworks, including ASEAN CTD, ICH guidelines, and country-specific requirements.
• Proven ability to manage multiple priorities and collaborate effectively with internal teams and external partners on regulatory matters.
• Solid interpersonal and communication abilities, with a detail-oriented and structured approach to documentation and compliance.

What you'll get in return

• Play a key role in shaping regulatory strategies across diverse international markets, driving access to healthcare solutions globally.
• Work closely with dynamic teams across Regulatory, Quality, Business, and Pharmacovigilance to influence strategic decisions.
• Expand your expertise in APAC regulatory frameworks while managing end-to-end submissions and lifecycle activities in a fast-paced, multicultural environment.

What you need to do now

If you feel like you meet the above requirements or know someone who does, then click on the link to apply, or, you may send your application/referral directly to me at

EA Reg Number: R

EA License Number: 07C3924 | Company Registration No: D

At Majeton, we are driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products.

We are seeking a meticulous and experienced Quality & Regulatory Affairs Specialist to join our team and ensure regulatory compliance, uphold product quality, and oversee vigilance reporting for all of our marketed products.

What you will do:

Quality Assurance (QA)

• Handle and manage local annual GDPMDS and GDP inspection; support inspection readiness
• Maintain and manage all controls of documents and records
• Manage and maintain local GDPMDS and GDP SOP and system records, including but not limited to all product complaints, returns, disposal, internal inspection/ audit, deviation,CAPA management, etc
• Manage new and existing supplier management activities
• Perform personnel training to ensure regulatory and quality compliance

Regulatory Affairs & Pharmacovigilance (RA & PV)

• Manage and process AE intake for all products
• Perform signal detection
• Manage compliance of all PV SOPs
• Provide regulatory support in RA activities

You are someone who:

• Holds a Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
• Has at least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PV
• Is familiar with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDP
• Has experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)
• Demonstrates strong documentation, regulatory filing, and communication skills
• Is eager to grow with the company and open to cross-functional learning and development
• Is ready to take on more responsibilities within the Quality & Regulatory Affairs domain; training and mentorship provided
• Is adaptable and willing to support the team with ad hoc tasks when required.

It's a bonus if you also have:

• Knowledge or exposure to US FDA biologic regulations and pharmacovigilance systems
• Experience in SME distribution companies or startup environments
• Experience in preparing for inspection readiness

What we offer:

• Competitive salary and performance-based bonuses
• Opportunities for professional growth and development
• Coffee treats from our generous bosses
• A team of hard-working colleagues who work hard and play hard

• 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.

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.

Job Description

• Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global markets
• Craft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen focus on guiding projects from initial concept to market delivery.
• Direct and manage cross-functional teams for regulatory submissions, fostering relationships with senior leadership and ensuring regulatory milestones are met.
• Monitor the development of regulatory submission plans for pivotal projects/products, maintaining a clear trajectory from inception through to successful project completion.
• Provide strategic leadership to the Regional Regulatory team, Health Authorities, and external partners, ensuring quality and compliance in all outsourced activities.
  Act as a mentor and coach, empowering team members with enhanced skills in project management, publishing, and regulatory practices, driving projects from their commencement to their conclusion.

Requirements

• Possess a bachelor's degree in a scientific or related field.
• Bring a minimum of 10 years of regulatory affairs experience within the pharmaceutical industry, with a substantial focus on managing the full lifecycle of regulatory strategies and submissions.
• Demonstrate an extensive understanding of regulatory requirements and guidelines within the Asia Pacific region, adaptable to the regulatory environments of the expanding MENA market.
• Have a proven ability to lead and manage cross-functional teams and navigate complex regulatory submissions from inception to completion.
• Exhibit superior project management skills, with a history of achieving key project milestones and delivering projects to completion.
• Maintain strong leadership and communication abilities, capable of influencing senior stakeholders and leading a team in a high-performance culture.
• Display commitment to professional development of team members, with a track record of mentoring and driving performance.
• Utilize excellent organizational skills to manage multiple projects simultaneously, ensuring attention to detail and a solution-oriented mindset.