Senior Regulatory Compliance Expert

3 days ago

Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 15,00,000

The role of Senior Regulatory Affairs Specialist requires strategic leadership in managing the lifecycle of regulatory activities for USFDA submissions.

As a key member, you will oversee the preparation, review, and filing of ANDA submissions, Annual Reports, amendments, and deficiency responses. You will collaborate with cross-functional teams to gather required documentation and data.

Your expertise in regulatory affairs will be instrumental in ensuring compliance with relevant regulations, including reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.

You will coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements. Additionally, you will stay updated on evolving USFDA regulations and provide strategic guidance.

The ideal candidate should possess 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings, particularly in ANDAs. A strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products is essential.

The successful candidate will have experience in preparing and reviewing technical documents, quality systems, BMR review, and interacting with production/plant teams.

In this role, you will utilize your expertise to drive strategic growth and innovation while maintaining regulatory compliance.

This position offers opportunities for professional development and growth within a dynamic organization.

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