Regulatory Affairs Specialist - US Market (Formulation RA)

The role of Formulation Regulatory Affairs Assistant Manager/Deputy Manager in the US Market requires a candidate with 7-10 years of experience and a qualification of M. Pharma / M.Sc. The responsibilities include hands-on experience in the preparation, review, and submission of ANDA/ANDS in the US Market, as well as expertise in life cycle management for products filed in the US market. The candidate should possess comprehensive knowledge of regulatory guidelines/requirements and provide necessary regulatory inputs to cross-functional teams during product development and manufacturing stages. Understanding US regulatory submission requirements, maintaining regulatory databases, and publishing regulatory dossiers in eCTD format are key responsibilities. Reviewing technical documentations for dossier submission is also part of the role. The ideal candidate should have hands-on expertise in ANDA/ANDS filing, a stable background in a Pharma company, experience with US submissions, and familiarity with regulatory guidelines. Interested candidates with relevant experience are requested to share their CVs by emailing rashmi.gupta@biocon.com. When applying, candidates are required to mention their total experience, current CTC, total number of ANDA/ANDS filings, involvement in pre-approval activities, notice period, and willingness to work onsite in Bangalore (5 days working).,