Regulatory Compliance Specialist

5 days ago

Aurangabad, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

Job Summary

We are seeking a seasoned Regulatory Compliance Specialist to lead our team in managing complex regulatory affairs for US FDA submissions, including ANDA preparation, review, and filing.

About the Role

The ideal candidate will have hands-on experience in Regulatory Affairs – CMC with US FDA filings, especially ANDAs. They will oversee the compilation and submission of Annual Reports, amendments, and deficiency responses while collaborating with cross-functional teams to gather required documentation and data.

Key Responsibilities

  • Direct and manage CMC regulatory activities for US FDA submissions, including ANDA preparation, review, and filing.
  • Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Collaborate with Quality Assurance, Production, and Research & Development teams to ensure compliance with regulatory requirements.
  • 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.

Requirements

  • 7-10 years of hands-on experience in Regulatory Affairs – CMC with US FDA filings, especially ANDAs.
  • A strong understanding of ICH, US FDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Experience in preparing and reviewing technical documents, such as Module 2 & 3 (CTD format).
  • Exposure to quality systems, BMR review, and interacting with production/plant teams.

Benefits

  • A competitive compensation package that rewards your expertise.
  • The opportunity to work with a dynamic team and contribute to the growth of our organization.

About Us

We are a forward-thinking organization dedicated to delivering high-quality solutions. Our team is passionate about making a difference in the industry, and we believe that our values align with yours.

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