Senior Manager Regulatory Affairs

Position:

Qualification:

Experience:

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.