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Assistant Manager Regulatory Affairs DDReg Pharma

4.0 - 8.0 years

0 Lacs

haryana

On-site

As an Assistant Manager Regulatory Affairs for EU & UK markets, your role involves driving CMC documentation, regulatory submissions, and lifecycle management to ensure compliance with regional and international guidelines. Your key responsibilities will include: - Conducting comprehensive CMC reviews of technical documentation for regulatory filings in the EU and UK markets. - Performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards. - Developing and implementing regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications. - Preparing and comp...

Posted 6 days ago

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