Regulatory Affairs Lead for Generic Product Compliance

2 days ago

Surat, Gujarat, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 50,00,000

**Job Title:** Senior Regulatory Affairs Specialist

 

About the Role:

We are seeking a seasoned professional to lead and manage CMC regulatory activities for USFDA submissions. As our ideal candidate, you will be responsible for overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses.

 

Main Responsibilities:

  • Lead and manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.
  • Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Collaborate 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 aligned with regulatory requirements.
  • Stay up-to-date on evolving USFDA regulations and provide strategic guidance.

 

Requirements:

  • A minimum of 7 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings, especially ANDAs.
  • A strong understanding of ICH, USFDA 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.
  • The ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.

 

Benefits:

This is an excellent opportunity for a highly skilled Regulatory Affairs professional to take their career to the next level. If you have the necessary skills and experience, we encourage you to apply for this challenging role.

 

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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