Senior Regulatory Compliance Officer

1 day ago


Salem, Tamil Nadu, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000
Key Responsibilities:
  • Lead and manage regulatory activities for US FDA submissions, including ANDA preparation, review, and filing.
  • Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Interface with cross-functional teams to gather required documentation and data.
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Coordinate with manufacturing units to ensure product and process compliance aligns with regulatory requirements.
  • Stay updated on evolving US FDA regulations and provide impact assessment and strategic guidance.

Required Skills and Qualifications:

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

What We Offer:

  • Developing and implementing effective regulatory strategies to meet business objectives.
  • Collaborating with cross-functional teams to ensure alignment and compliance with regulatory requirements.
  • Providing expert advice and guidance on regulatory matters to internal stakeholders.
  • Staying up-to-date with changing regulatory landscapes and providing recommendations for updates to policies and procedures.
  • Preparing and submitting regulatory documents, including reports, amendments, and responses.

Requirements:

  • Advanced degree in a relevant field.
  • Professional certifications and/or membership in industry organizations.
  • Excellent communication, interpersonal, and project management skills.
  • Ability to work effectively in a fast-paced environment with multiple priorities and deadlines.


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