Senior Executive -Global Regulatory Development Centre

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