- 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.
- Min Bachelor in pharmacy
- Minimum 5 years' of regulatory experience in pharma industry
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Regulatory Affairs Manager - Singapore - RECRUIT EXPRESS PTE LTD
Description
Roles & ResponsibilitiesJob Scope
Requirement
Basic salary: $7K to $8K
Interested applicants, please email your updated CV to
Consultant: Huang Jingsheng Kevyn (R
Recruit Express Pte Ltd (99C4599)
Tell employers what skills you haveFDA
Regulatory Compliance
Interpersonal Skills
Regulatory Affairs
ISO
Market Access
Clinical Development
Biology
Authorization
Medical Devices
Pharmacology
Regulatory Requirements
Life Sciences
Manufacturing
Personal Development