Job Scope
- Supports JAPAC RA affiliates and Global RA in Marketing Authorization (MA) and clinical development related activities for the assigned projects.
- Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction 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 intercontinental commercial, market access and medical 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 for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
- Manages clinical development, clinical trial, new drug applications and lifecycle activities for the assigned projects to ensure regulatory requirements are met and optimal regulatory strategies are reached.
Requirement
- Min Bachelor in pharmacy
- Minimum 5 years’ of regulatory experience in pharma industry
Basic salary: $7K to $8K
Interested applicants, please email your updated CV to [email protected]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
