Senior Manager Regulatory Affairs

23 hours ago

Delhi, Delhi, India Panacea Biotec Full time ₹ 10,400 - ₹ 13,08,780 per year

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.

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