Regulatory Affairs Expertise Wanted

2 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 40,00,000 - ₹ 50,00,000
Job Summary:

We seek an accomplished Regulatory Affairs Specialist to serve as Assistant Manager / Manager Regulatory Affairs – Complex Products.

The ideal candidate will possess a minimum of 10+ years' experience in the pharmaceutical industry with expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU markets.

  • Preparation and Submission of Pre-IND meetings Request and Packages and IND/NDA submissions ensuring compliance with FDA & EMA.
  • Define nonclinical and clinical study requirements for 505(b)(2), including bridging studies.
  • CTD dossier preparation (Modules 1-5) and CMC document review.
  • Address comparability studies, bioequivalence challenges, and formulation complexities.
  • Manage post-approval variations, renewals, and compliance updates.
  • Engage in EMA scientific advice meetings and FDA Pre-IND consultations.
Required Skills:
  • Expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU.
  • Strong knowledge of EMA/FDA guidelines, clinical trial regulations, and GMP standards.
  • Experience with eCTD submissions, CMC documentation, and regulatory risk mitigation.
  • Familiarity with eCTD software's for regulatory submissions.
  • Experience on the labeling updates required for complex product for 505b2.
  • Experience on Pediatric Study Plan Submission and Approval, Post approval Study Requirements
  • Experience on PDUFA Fees Requirements and Waiver Applications
Preferred Education:

Bachelor's/master's in pharmacy, or Regulatory Affairs. Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.

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