October 2025

Ensures proper archiving of submission documentation and compliance with internal SOPs. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.

This position provide active involvement and contribution in the Formulation R&D team in terms of technical and operational activities such as hands-on support to formulation development in parenteral formulations and interpretation of analytical results. The incumbent will perform other duties as assigned.

Capsule Filling Machine Operation/ Batch Execution & Process Control/ Safety & EHS Awareness

B.Pharm / M. Pharm with experience in R&D or a related role. Strong Analytical, Problem-solving, and Critical thinking skills., Excellent Communication and Coordination skills.

Regualtory Specialist II supports a team in the preparation and maintenance of complete and accurate regulatory documents in support of clinical research studies

Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry CDISC and regulatory compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.

The Central Drugs Standard Control Organization (CDSCO) has issued a directive to all State and Union Territory Drug Controllers, stressing the need for strict compliance with the Drugs Rules, 1945, in testing raw materials and finished pharmaceutical formulations.

Professionals having proven competency and success in conducting Quality Assurance and / or managing studies under GLP (Good Laboratory Practice environment, with at least 10 years of post- qualification experience, and should possess M.Sc./ M.V.Sc. / M.Pharm / M. Tech qualification.