
Formulation Development Scientist
19 hours 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
-
Formulation Scientist
1 week ago
India Dr. Reddy's Laboratories Full timeCompany DescriptionDr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...
-
Formulation Scientist
6 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market SupportLocation: Mumbai, IndiaAbout the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation Scientist
7 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market SupportLocation: Mumbai, IndiaAbout the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation scientist
6 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market Support Location: Mumbai, India About the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation Scientist
5 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market SupportLocation: Mumbai, IndiaAbout the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation Scientist
7 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market Support Location: Mumbai, India About the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation Scientist
6 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market SupportLocation: Mumbai, IndiaAbout the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation Scientist
7 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market Support Location: Mumbai, India About the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support...
-
Formulation Scientist
6 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market Support Location: Mumbai, India About the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...
-
Formulation Scientist
7 days ago
Mumbai, India TheRecAI Full timeJob Title: Formulation Manager - Pharma for Generic Market SupportLocation: Mumbai, IndiaAbout the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical...