Regional Regulatory Affairs Associate
Confirmed on the employer's own hiring board on Nov 15, 2026. First seen by Alion on Nov 13, 2026. EMD Group scores A on the Alion truth index.
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.
Your Role:
We are looking for a motivated and detail-oriented APAC RA Regional Hub Associate to join our Regulatory Affairs team. In this role, you will be responsible for executing regulatory submissions across assigned Asian countries, supporting regional and global strategies, and ensuring timely product approvals and compliance. You will work closely with cross-functional teams and contribute to the continuous improvement of our regulatory processes.
Key Responsibilities
Regulatory Submissions & Compliance
- Execute all regulatory submissions in assigned Asian countries per regulatory and business requirements.
- Ensure ready-to-submit dossiers are available as per respective country requirements through timely dossier compilation.
- Coordinate labelling compliance and support the promotional material review process.
- Track regulatory activities for assigned countries and portfolio in relevant company systems.
- Review and assess health authority regulations and competitor intelligence across Asia.
As Regional Product Lead (RPL)
- Monitor pipeline and support program/project development.
- Collect data for RA Strategy for new Marketing Authorization Applications (MAA) and Life Cycle Management (LCM).
- Provide support for Early Access Programs (EAP) and Named Patient Sales (NPS).
- Ensure effective communication across RA (top-down and bottom-up) and knowledge sharing about pipeline and portfolio.
- Validate requirements for strategy development and contribute to new project roll-out strategies.
- Act as regional RA representative at cross-functional interactions and meetings.
- Oversee dossier availability for LCM and new MAA by collaborating with PPD/REC/GRA/CRA/POC.
- Ensure timely submission and dispatch of dossiers and timely Veeva Vault updates.
- Follow up on approval status of LCM and new MAA in the APAC region and share regular updates with global and regional cross-functional teams.
- Ensure timely AtO preparation, submission, and dispatch for LCM and new MAA.
- Support the regional TA Coordinator in crisis coordination and management processes.
As Country Point of Contact (PoC) / Sub PoC
- Manage Early Access Programs (EAP) and Named Patient Sales (NPS) in the country in coordination with the RPL.
- Provide RA strategy input on commercial business cases and country requirements for new projects.
- Engage with country Health Authorities (HA) and ensure timely submission of dossiers for zero-based countries.
- Receive and communicate approval status from HA to RPL and RAA.
- Provide country intelligence to RPL for regulatory assessments and dossier preparation.
- Coordinate with local stakeholders and manage country-specific activities (e.g., Audit, Change Control, Promotional Material Review, Special Permit, Packaging Materials, Tender, HA Inspections, Import License).
- Participate in HA and industry meetings.
- Manage external consultants and business partners, when applicable.
Who You Are:
- Bachelor’s degree in Pharmacy.
- Experience in Regulatory Affairs within the pharmaceutical or healthcare industry, preferably in the APAC region.
- Solid understanding of regulatory submission processes and health authority requirements across Asian markets.
- Familiarity with dossier preparation, LCM, and MAA processes.
- Experience working with Veeva Vault or similar regulatory document management systems is an advantage.
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Excellent communication and interpersonal skills for cross-functional collaboration.
- Ability to travel as per business needs.
- Proficiency in English; additional Asian language skills are a plus.
Why Join Us?
We are a vibrant science and technology company. We believe in the power of curious minds to create a better world. We offer:
- A collaborative and inclusive work environment that values diversity.
- Opportunities for continuous learning and professional development.
- Competitive compensation and benefits package.
- The chance to make a meaningful impact on patients’ lives through innovative healthcare solutions.
- A global network of talented colleagues across more than 65 countries.
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!