Assistant/Deputy Manager-Regulatory Affairs(Europe Mkt-Formulations)
2 weeks ago
Dear All,
We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-10 years of experience in pharmaceutical formulations, specifically for the Europe market.
Key Responsibilities:
- Prepare, compile, and submit high-quality regulatory dossiers in compliance with EU and UK market requirements.
- Collaborate with cross-functional teams (CFTs) to ensure alignment with regulatory standards and timely compliance
- Maintain accurate and up-to-date regulatory documentation and manage regulatory databases effectively.
- Demonstrate strong communication skills to engage with internal teams and external regulatory authorities.
- Possess in-depth knowledge of EU regulatory guidance, procedures, and submission pathways
- Understand and manage post-approval variation requirements specific to EU & UK markets.
- Good knowledge on review of quality documents
- Address regulatory queries promptly and ensure timely submission of required responses.
- Monitor evolving regulatory requirements and communicate relevant updates to internal stakeholders
Interested candidates can share their resumes to
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