Strategic Regulatory Leader

3 days ago


Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 35,00,000 - ₹ 48,29,900
Regulatory Affairs Manager Job Description

The ideal candidate for this role will be responsible for ensuring regulatory compliance across the US, European and UK market.

This position requires a highly skilled and experienced professional who can manage complex drug approvals, comparability studies, bioequivalence challenges, and formulation complexities. Strong communication skills and ability to engage in scientific advice meetings and consultations are necessary.

Key responsibilities include preparation and submission of Pre-IND meetings Request and Packages, IND/NDA submissions, CTD dossier preparation, and management of post-approval variations.

A strong knowledge of EMA/FDA guidelines, clinical trial regulations, and GMP standards is required. Experience with eCTD submissions, CMC documentation, and regulatory risk mitigation is also essential. Familiarity with eCTD software's for regulatory submissions is preferred.

Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies is an added advantage. Bachelor's/master's in pharmacy, or Regulatory Affairs is the minimum educational requirement.



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