Role & responsibilities

Key Responsibilities:

API Process Development & Optimization:
Perform feasibility studies, process optimization, and scale-up of API processes. Conduct process verification and identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
Plan lab work, prepare Reference Standards (RS)/Working Standards (WS), and ensure their characterization.
Initiate the technology transfer process to the pilot plant or production facility.

Regulatory Affairs & Compliance Support:
Provide timely technical support for regulatory queries, especially those related to DMF preparation.
Ensure accurate preparation of specification sheets and MSDS for raw materials and intermediates.




Prepare the Development History Report for regulatory submission and archival. Conduct initial stability studies for developed products.

Cross-Functional Coordination:
Coordinate with the Regulatory Affairs (RA), Analytical Development Lab (ADL), IPR, and Development Quality Assurance (DQA) teams.
Manage coordination between officers working in R&D.;

Required Qualifications & Experience:
Education: M.Sc. (Organic Chemistry) or Ph.D. (Organic Chemistry) Experience: 2 to 8 years of relevant experience

📌 Senior Executive Global Regulatory Deficiency Centre Navi Mumbai
🏢 Aarti Pharmalabs
📍 Navi Mumbai