Associate RA Manager - HN

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 Vietnam

Location working: Hanoi city

Your Roles:

• Independently perform regulatory activities in order to support successful local approvals of new marketing authorization and maintaining Marketing Authorizations including renewal, variations, site registration, originator and tenders related submission during the lifecycle of assigned products.
• Provide strategic input to projects to align with business objectives.
• Demonstrate expertise in regulations for Drug and Medical device.

What You Should Do:

• Develop and implement effective regulatory strategies for assigned projects, including risk mitigation plans and critical reviews of regulatory submissions.
• Manage all regulatory activities for assigned projects and products.
• Track and expedite submissions with high impacts; ensuring timely follow up to meet the targeted approval timeline.
• Develop and manages optimal labeling for all products throughout the product lifecycle in close alignment with global labeling group.
• Monitor the regulatory environment/local regulatory partners/stakeholders, and assess impact on the portfolio, communicating updates and developing mitigation plans. Works on mitigation plan to optimize submission strategies and maximize business benefit.
• Maintain communication with affiliates for regulatory requests and information exchange.
• Ensure compliance with local regulations and corporate policies and procedures.
• Manage documentation and ensure accurate data entry in regulatory databases.
• Ensures timely and accurate data entry/maintenance into databases, online systems.
• Handle administrative tasks for the Regulatory Affairs team as assigned.
• Collaborate with departments on supply, quality matters, and tender support.
• Work with GPS and local Medical on PSUR and PV activities.

Who you are:

• Bachelor of Pharmacy University
• At least 05 year of experience in Regulatory Affairs in Pharmaceuticals & Medical device Industry; imported product & MNC organization is preferred.
• Strong experience in dossier compilation & ensuring regulatory compliances in accrodance with current regulations & laws.
• Proven ability to build trust & maintain effective relationship with Health Authorities and Experts both from the North or the South.
• Capable of independently following up on the dossier with Drug Administation, demonstating a high impact. Significant achievements in Site registration, reference biologics and innovator listing are preferred.
• Familiarity with regulatory management systems.
• Detailed-oriented, well-organized & a strong team player.
• High accountability with result-oriented approach.
• Effective communication skills.
• Agile & capable of leading works independently.
• Fluency in English for direct & daily communication with global/region teams.
• Proficient in computer and software 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!