Description:
- Supports JAPAC affiliates and Global Regulatory Affairs in Marketing Authorization (MA) related activities for the assigned projects
- Manages interface with Affiliate/Agency for key projects/issues, including direct/indirect negotiation with regulatory agencies.
- Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
- Partners with JAPAC commercial area to ensure business needs are met.
- Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
- Assesses scientific data provided by specialist units for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
- Manages lifecycle activities for the assigned projects to ensure regulatory requirements are met
Requirements:
- Min. Degree in any Science-related discipline
- Min. 1-2 years of any regulatory affairs manager experience
Interested candidates, please forward your resume to [email protected]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
