Regulatory Affairs Manager (Pharma MNC, 1 Year contract, $7K to $8K) #HKH

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)

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