Formulation Development Scientist
3 weeks ago
Job Description
Role & responsibilities
- Nitrosamine and regulatory query support
- Conduct nitrosamine risk assessments for APIs, excipients, packaging components, and finished drug products.
- Evaluate manufacturing processes, raw materials, and excipients for nitrosamine risk.
- Review current regulatory guidelines (ICH M7, EMA, USFDA, CDSCO, WHO, and other ROW countries) and apply them in assessments.
- Prepare risk assessment and justification reports for internal and regulatory submission.
- Work with Analytical Development, Quality Assurance, Regulatory Affairs, and Formulation teams to collect and interpret required data.
- Support confirmatory testing strategies and assist in root cause investigations if nitrosamines are detected.
- Maintain awareness of evolving global guidance on nitrosamine impurities.
- Manage regulatory queries from ROW health authorities (Asia-Pacific, LATAM, Middle East, Africa, CIS, etc.).
- Coordinate with Formulation Development, Analytical, Quality, and Manufacturing teams to collect supporting data.
- Prepare query response packages, clarifications, and justifications in line with agency expectations.
- Support dossier maintenance (CTD/ACTD/eCTD formats) and post-approval submissions.
- Track, monitor, and ensure timely closure of queries to avoid approval delays.
- Stay updated with ROW regulatory guidelines and requirements.
- Maintain internal databases/documentation related to submissions and queries.
- MFR, SP/SR preparation based on need.
Job Location - Mumbai Jogeshwari
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