- Support JAPAC Affiliates and Global Regulatory Affairs:Collaborate with cross-functional teams to facilitate Marketing Authorization (MA) activities for assigned projects.
Engage in direct and indirect negotiations with regulatory agencies to ensure successful outcomes.
- Implement Regulatory Strategies:Develop and execute regulatory strategies for assigned projects in alignment with commercial priorities.
Work closely with the Global Regulatory Lead and other RA sub-team members to achieve project goals.
- Partnership with Commercial Teams:Liaise with Intercontinental commercial teams to address business needs and regulatory requirements.
Ensure seamless integration of regulatory considerations into commercial initiatives.
- Represent Regulatory Function:Present regulatory requirements and commercial interests at sub-teams and client group meetings.
Advocate for compliance and strategic input during product registration processes.
- Scientific Data Assessment:Evaluate scientific data provided by specialist units against JAPAC regulatory and clinical standards.
Identify gaps and develop mitigation strategies to address any deficiencies.
- Documentation and Compliance:Compile and prepare regulatory dossiers and documents for local registration requirements.
Ensure adherence to regulatory guidelines and implement remediation plans as needed.
- Area Regulatory Initiatives:Support JAPAC affiliates in regional regulatory initiatives.
Requirement
- Min. Bachelor’s degree in a relevant field (e.g., life sciences, pharmacy, or related discipline).
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
- Strong knowledge of JAPAC regulatory requirements and guidelines.
- Excellent communication and negotiation skills.
- Detail-oriented and able to manage multiple tasks simultaneously.
Interested candidates, do submit your resume in Word document to: [email protected] or telegram @alexgohhl
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
