· Manages devices products related lifecycle activities for the assigned projects to ensure regulatory requirements are met
· Supports JAPAC Area RA Lead, affiliates and Global Regulatory Affairs in variation related activities (i.e. regulatory assessment, etc.) for the assigned projects
· Implements regulatory strategies for the assigned projects for countries in JAPAC under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.
- Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial, R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products.
- Interfaces with JAPAC cross functional teams as appropriate and partners with JAPAC commercial teams to ensure business needs are met.
- Represents the JAPAC regulatory function at sub-teams to present regulatory requirements and commercial interests on the Global Regulatory Product Team (GRPT) to ensure those are met.
- Ensures regulatory compliance for the assigned Assets/products. Implements remediation plan to address identified gaps, if any.
- Supports regulatory initiatives for JAPAC Area team.
Education / Experience Required:
- Min Degree in pharmacy, pharmacology, bioengineering or related subject.
- Min 5 years of regulatory affairs in medical devices
- Has pior experience in China/Japan registration / support role in the past
If you meet the requirements of this role, please email a detailed resume to [email protected] or telegram @alexgohhl
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
