Senior Regulatory Affairs Specialist
1 month ago
Salary: up to $6.5k
Job Duration: June 1st 2024 â€' May 31st 2025
Working Days & Hours: Mon - Fri Office Hours
Location: Buona Vista
Job Description:
- 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.
Job Requirements: Min Degree in Pharmacy/Biology with 5 years relevant experience
Interested candidates, please submit your resume to:
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
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