Senior Manager Regulatory Affairs

Position :

Sr. Manager / AGM – Regulatory Affairs

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.