Regulatory Affairs Expert

2 days ago

Meerut, Uttar Pradesh, India beBeeRegulatory Full time ₹ 13,80,000 - ₹ 21,60,000
Job Description

This role entails overseeing regulatory activities for FDA submissions, encompassing ANDA preparation, review, and filing. Key responsibilities involve managing CMC regulatory activities, coordinating compilation and submission of Annual Reports, and ensuring compliance with Batch Manufacturing Records.

Key tasks include:

  • Lead Regulatory Activities: Oversee CMC regulatory activities for FDA submissions, including ANDA preparation, review, and filing.
  • Compile and Submit Reports: Coordinate compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Interface with Cross-Functional Teams: Interface with cross-functional teams, including Quality Assurance, Production, and R&D, to gather required documentation and data.
  • Review Compliance Documents: Review and ensure compliance of Batch Manufacturing Records, process validation documents, and site-related data.
  • Coordinate with Manufacturing Units: Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Stay Updated on Regulations: Stay updated on evolving FDA regulations and provide impact assessment and strategic guidance.
Required Skills and Qualifications

To be successful in this position, you will require:

  • Regulatory Experience: 7–10 years of hands-on experience in Regulatory Affairs – CMC with FDA filings (especially ANDAs).
  • Strong Understanding: Strong understanding of ICH, FDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Document Preparation: Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  • Quality Systems Exposure: Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • Submission Lifecycle: Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with FDA.
Benefits

This role offers a range of benefits, including:

  • A competitive salary.
  • A comprehensive benefits package.
  • Ongoing training and development opportunities.

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