
Regulatory Affairs Expert
2 weeks ago
The ideal candidate will possess a strong background in regulatory affairs, with a focus on chemical, manufacturing, and controls (CMC) aspects.
Key Responsibilities:
- Oversee the compilation and submission of 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 guarantee product and process compliance aligned with regulatory requirements.
- Stay updated on evolving regulations and provide impact assessments and strategic guidance to stakeholders.
Required Skills and Qualifications:
- A minimum of 7-10 years of hands-on experience in regulatory affairs – CMC with USFDA filings, particularly ANDAs.
- 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.
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