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Panacea Biotec

4 weeks ago

Gurgaon, India Panacea Biotec Full time

Position: Sr. Manager / AGM Regulatory Affairs


Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related 13 to 16 years in Regulatory Affairs The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory compliance/audit support. The role ensures accurate and compliant representation in dossiers, while guiding strategy for regulatory filings, variations, and lifecycle management across multiple regions.


Key Responsibilities:


- Deep expertise in vaccine/biological regulatory affairs, dossier preparation, and lifecycle management.


- Strong track record in WHO PQ filings, country registrations in LatAm & Africa, and handling audits/inspections.


- Hands-on experience in CMC data review, comparability, and technology transfer from development to commercial sites.


- Skilled in managing confidential proprietary know-how within regulatory frameworks.


- Leadership ability to guide teams, engage with regulators, and drive cross-functional compliance.


- Prepare and review CTD/ACTD/eCTD dossiers, ensuring accuracy and compliance with regional requirements.


- Confidential Know-How Custodian: Manage proprietary technical information (cell substrates, seeds, process steps, validation data, excipients, DS/DP composition) and ensure controlled incorporation into dossiers.


- Lead post-approval variations, change controls, and license renewals/maintenance across client countries.


- Drive pre-submission strategy, dossier compilation, regulatory liaison, and post-PQ lifecycle management.


- Provide country-specific CMC requirements to R&D; guide teams on comparability, validation, and regulatory responses.


- Ensure regulatory guidance and documentation compliance during product/site transfers/Tech transfer.


- Prepare responses to regulatory queries, coordinate with bulk suppliers for PAC filings, and represent the company during inspections.


- Mentor and upskill subordinates; build regulatory capability aligned to evolving global requirements.


Liaison with Regulatory Authorities:


Candidate Profile:


- Proven expertise in vaccine/biological product regulatory affairs, including WHO PQ and multi-regional registrations.


- Strong knowledge of CMC, comparability, process validation, and lifecycle change management.


- Experience liaising with regulators, managing audits, and preparing PSURs/SAE submissions.


- Ability to lead teams, safeguard confidential technical know-how, and drive regulatory compliance across geographies.

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