
Senior Regulatory Compliance Specialist
5 days ago
Job Summary
We are seeking a highly experienced and skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in managing CMC regulatory activities, including USFDA submissions, and ensuring compliance with regulatory requirements.
Main Responsibilities:
- Develop and implement effective strategies for USFDA filings, focusing on ANDA preparation, review, and submission.
- Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses, ensuring timely and accurate delivery.
- Collaborate with cross-functional teams to gather required documentation and data, facilitating seamless project execution.
- Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data, maintaining high standards of quality.
- Cultivate strong relationships with manufacturing units to ensure product and process compliance aligns with regulatory requirements.
- Stay updated on evolving USFDA regulations and provide strategic guidance to drive informed decision-making.
Key Qualifications:
- 7–10 years of experience in Regulatory Affairs – CMC with USFDA filings, especially ANDAs.
- Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
- Proven ability to prepare and review technical documents, including Module 2 & 3 (CTD format).
- Experience in 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 USFDA.
About This Role
This is an exciting opportunity to work in a dynamic environment where you can leverage your expertise to drive regulatory compliance and contribute to the success of our organization.
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