Formulation Development Scientist; Nitrosamine

Position: 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