Assistant Manager
7 days ago
Key Responsibilities:
Regulatory Support & DMF Filing:
Support the Regulatory Affairs team in the preparation, compilation, and submission of Drug Master Files (DMFs) for new products across different regulatory agencies.
Coordinate with cross-functional teams (QA, QC, Production, R&D) for timely data collection and documentation.
Regulatory Deficiencies & Queries:
Review, analyze, and address regulatory deficiencies raised by authorities within stipulated timelines.
Prepare clear and concise responses to regulatory queries in coordination with internal departments.
Assessment & Amendments:
Prepare and review country-specific regulatory assessments and amendments based on current regulatory guidelines and product variations.
Ensure compliance with regional submission formats and documentation requirements.
Customer Communication:
Address customer queries related to DMF and regulatory documentation promptly and professionally.
Provide technical support to customers for regulatory submissions and clarifications.
Regulatory Compliance:
Maintain up-to-date knowledge of global regulatory guidelines, compliance requirements, and submission procedures.
- Support audits and inspections by ensuring accuracy and completeness of regulatory documentation.
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