
Regulatory Compliance Specialist
2 days ago
Job Overview
">The role of a Regulatory Compliance Manager involves ensuring adherence to regulatory requirements for new products and variations in the US market. This includes reviewing and preparing CMC dossiers, stability protocols, and analytical validation reports.
">Key Responsibilities
">- Review and prepare CMC dossiers for fresh submissions
- Review documents including development reports, scale-up reports, specifications, and stability protocols
- Prepare and review response to deficiency enabling approval of products filed to regulatory agency
- Lifecycle management for drug formulations, including preparation and review of variation and annual notification
- Regulatory compliance, including eCTD compilation and repositioning of comprehensive product information into central repository
Requirements
">• M Sc, B Pharm, or M Pharm degree
">• 8-12 years of experience in Regulatory Affairs
">Benefits
">At Sun Pharma, your success and well-being are our top priorities. We provide robust benefits and opportunities to foster personal and professional growth.
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