Regulatory Affairs Manager

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Report to: Head of Regulatory Affairs

Location: Ho Chi Minh city

Main duties: 

• Lead regulatory strategy for projects aligned with business objectives.
• Own end-to-end portfolio: new MA, variations, extensions, site registration, tenders, promotional activities, biologics (innovator/reference), import licenses.
• Provide expertise across chemical drugs, biologics, and medical devices.
• Drive regulatory intelligence and policy advocacy.

Your roles: 

• Develop and execute regulatory strategies, including risk mitigation and critical review of submissions.
• Manage end-to-end regulatory activities for assigned products/projects.
• Track, expedite, and follow up high-impact submissions to ensure timely approvals.
• Lead lifecycle labeling strategy in alignment with global teams.
• Monitor regulatory environment and stakeholders; assess impact and implement mitigation plans to optimize submissions.
• Lead regulatory communication with internal and external stakeholders (health authorities, partners, affiliates), ensuring alignment and proactive issue resolution.
• Maintain communication with affiliates for regulatory coordination and information exchange.
• Ensure compliance with local regulations and corporate policies.
• Manage regulatory documentation and ensure accurate, timely database entry.
• Handle assigned administrative tasks for the RA team.
• Collaborate cross-functionally on commercial, supply, quality, and tender activities.
• Coordinate with GPS and Medical on PSUR and pharmacovigilance activities.

Who you are:

• Bachelor of Pharmacy; Master’s degree preferred.
• At least 8 years in Regulatory Affairs (Pharma), including at least 2 years at RA Manager level; experience with imported products and medical devices preferred.
• Strong experience in innovative drug applications.
• Able to independently manage drug registration dossiers with DAV and clinical trial submissions to ASTT, delivering high performance.
• Proven ability to build trust and maintain effective relationships with Health Authorities and Experts.
• Translate regulatory policies into action plans.
• Proficient in regulatory management systems.
• Detailed-oriented, well-organized & a strong team player.
• Agile and high ownership and accountability.
• Strong problem-solving under ambiguity.
• Influencing without authority.
• Execution discipline and proactive follow-up.
• Effective communication skills.
• Fluency in English.
• Proficient in computer and AI usage.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!