Formulation Development Scientist (Nitrosamine)

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

• Location - Jogeshwari Mumbai
• Experience - 5+ Years