
Pharmaceutical Regulatory Expert
15 hours ago
The Regulatory Affairs Senior Specialist plays a pivotal role in ensuring the quality and compliance of partnered products. Key responsibilities include thorough due diligence, regulatory submissions, partnership coordination, renewals, documentation, and quality assurance.
- Evaluate in-licensed product dossiers for adherence to regulatory requirements and market readiness.
- Conduct risk assessments for out-licensed products with partners to ensure alignment with business objectives.
Key Responsibilities:
- Due Diligence and Assessment
- Regulatory Submissions
- Partnership Coordination
- Renewals and Lifecycle Management
- Documentation and Communication
- Quality Assurance and Compliance
This position requires a licensed pharmacist with at least 7 years of experience in Regulatory Affairs, including liaison with regulatory authorities, and an understanding of FDA, ASEAN, WHO, and ICH guidelines. The ideal candidate will possess excellent analytical skills, attention to detail, and the ability to communicate complex information effectively.
As a full-time employee in Pharmaceutical Manufacturing, this role offers opportunities for growth and development in a dynamic environment.
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Regulatory Compliance Expert
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