Senior Manager Regulatory Affairs
3 weeks ago
Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)
Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)
Role:
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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