Maharashtra

Develop and implement effective regulatory strategies and pathways for Sanofi products to enable timely market authorization and product launches

Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned global deliverables in the maintenance Center of Excellence, as an individual contributor.

Serve as a subject matter expert in regulatory affairs and medical writing for life sciences projects applying deep regulatory domain knowledge to develop compliant documentation and optimize regulatory business processes.

First level manager of a work team that may comprise professionals, technical and/or administrative staff. Typically without budget or hire/fire authority.

MSc / M.Tech / M.Pharm (Biotech / Biochemistry) Experience in HPLC/UPLC/CE based developments & method qualifications for therapeutic proteins

Masters degree in Chemistry or Biochemistry or Pharmacy or Pharmaceutical Chemistry or Pharmacology or Bacteriology or Medicine or Microbiology or Biotechnology from a recognised University or institute. in the Central Drugs Testing Laboratory, Mumbai, CDSCO

Graduation in Pharmacy or Biotechnology, with hands-on experience in Autoclave, Formulation, and Washing Area). candidate shoud have regulatory plant experiance USFDA and EMA.

Masters /Integrated Masters in Natural or Agricultural or Pharmaceutical Sciences. OR Doctoral Degree in Science/ Pharma/MD / MS from a recognized University or equivalent. National Chemical Laboratory Pune

Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met. Review, compile and dispatch new product submissions and pre-launch variations.