
Principal Regulatory Compliance Specialist
9 hours ago
The ideal candidate will be responsible for leading and managing CMC regulatory activities, including USFDA submissions.
Key Responsibilities:
- Compile and submit Annual Reports, amendments, and deficiency responses to ensure compliance with regulatory requirements.
- Interface with cross-functional teams to gather required documentation and data for submissions.
- 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 updated on evolving USFDA regulations and provide strategic guidance to the team.
Requirements:
- A minimum of 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings.
- 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.
- Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.
Why this role matters:
This position plays a critical role in ensuring our company's products meet regulatory standards, which ultimately affects public health and safety.
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