5+

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

Perform analysis of raw materials and finished products using UV, IR, HPLC, UPLC, GC, LCMS, etc. Ensure adherence to SOPs, GMP, and ALCOA principles during shift operations.

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 should have completed Ph.D. in their relevant discipline. SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulattur is one of the countrys premier pharmaceutical education and research institutions.

Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.

Dossier & document preparation as per CTD, ACTD & country specific guidelines, Review of dossiers, DMF & Technical documents, Answer query raised from regulatory authority.

Biological E. Limited (BE) invites both experienced professionals and fresh diploma holders, as well as graduates and self-driven individuals

Hetero is one of worlds leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector.