Formulation Development Scientist

3 days ago

Mumbai, Maharashtra, India NMS Consultant Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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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