Position Overview: As a Regulatory Affairs Manager, you will lead submissions and streamline regulatory processes to ensure product approvals in the APAC/Asia/ASEAN markets, while fostering collaboration and compliance with regional regulations.
Key Responsibilities
- Lead submissions and regulatory responses for new products in APAC/Asia/ASEAN.
- Develop efficient submission strategies for regional regulatory approvals.
- Foster cross-departmental collaboration for regulatory insights.
- Act as the primary internal regulatory contact for the region.
- Standardize regulatory processes to improve efficiency.
- Integrate regulatory information management systems.
- Support innovation and business development projects.
- Monitor regional regulatory changes and assess their impact.
- Gather competitive intelligence on regulatory matters.
Requirements
- 5+ years in APAC/Asia/ASEAN regulatory affairs (pharmaceutical, medical devices, consumer health)
- Experience in new registrations/variations/indications/renewals.
- Degree in Pharmacy, Life Sciences (or in a relevant field).
- Expertise in regional regulatory principals and experience managing communication and collaborations with health authorities.
- Strong multitasking, communication skills and great sense of team-work.
To apply, submit your most updated resume showcasing relevant qualifications and experience.
Not the right opportunity?
We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
