The Clinical Project Leader is responsible and accountable for start-up and follow up on Registries in close collaboration with Registry Team and Medical Affairs staff in the countries or locally.
Executing chemical reactions in mg to gm scale and to synthesize required quantities of molecules/compounds as per client specifications using efficient route and techniques.
Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams
Masters in Natural or Pharmaceutical Sciences/ MVSc/ Animal Sciences OR degree in Engineering or Technology or Medicine from a recognized University or equivalent
The candidate should have a Masters degree MS, M.Pharm, M.Tech, M.Sc. in Pharmaceutical chemistry, Organic chemistry, Process chemistry, Medicinal chemistry.
Track, organize, and manage the employee query queue using internal tools and systems. Coordinate with HR partners and other departments to ensure timely and effective resolution
Executing chemical reactions in mg to gm scale and to synthesize required quantities of molecules/compounds as per client specifications using efficient route and techniques.
Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.