Regulatory Affairs Specialist - CMC-Chemical/Biological Pharmaleaf India Pvt

2.0 - 6.0 years

0 Lacs

karnataka

On-site

As a Regulatory Affairs Associate, you will be required to hold a Master's Degree in M. Pharm or M. Sc. with a specialization in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Biochemistry, or Microbiology. A minimum of 2 to 6 years of hands-on experience in R&D within Manufacturing or Import companies, specifically in MNCs and Generics, is essential for this role. Proficiency in CDSCO and Central Licensing Agency - New Delhi (SUGAM) skills, including Agency Liaison, is a priority as applications lacking these skills will not be considered. Your responsibilities will include understanding new client requirements, scope, deliverables, and timelines, reviewing and finalizing Gap Analysis Reports, effective collaboration and communication with internal and external stakeholders, technical writing of regulatory documents, liaison with licensing authorities such as CDSCO, training internal technical team members on the latest updates and guidelines, and coordinating with stakeholders. Key responsibilities will involve Regulatory Strategy, KOL/SME/Agency and Network-Access, Review of Documents/Dossiers and Gap Analysis, and Technical Writing of Regulatory Documents. This is a full-time position with a day shift from Monday to Friday, based in Bangalore (Cunningham Road), serving the Indian market for API and Finished Formulation. A willingness to travel up to 25% of the time is required, with a start date of 04/08/2025, and the application deadline is 07/07/2025.,

Posted 2 weeks ago

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