First Class Post Graduate Degree, including the integrated PG degrees, with three Years Experience or PhD. Must have handled minimum five Projects relevant to the requirement as Principal Investigator or Co-PI.
M.Sc First Class with a Ph.D. degree in relevant Life Science subjects such as Biotechnology, Biochemistry, Molecular Biology, Genetics, Microbiology, or related disciplines from a recognized university.
Masters degree (M.Sc./M.Tech. /BS-MS dual degree or equivalent) in relevant field of Biology (Cell Biology, Developmental Biology, Molecular Biology, Biotechnology or other), with prior research experience.
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.
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.