Formulation Regulatory Affairs

2 weeks ago


Bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on life cycle management for the products filed in US market. Comprehensive and up-to-date knowledge on regulatory guidelines/requirements. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing. Responsible to understand the requirements related to US regulatory submissions. Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received. Publishing the necessary regulatory dossiers into eCTD format as per the country requirement. Review of technical (developmental and plant) documentations required for dossier submission. Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com Required skills :- Hands on ANDA/ANDS Filing expertise A stable candidate from Pharma company Should have exp of US Submissions Well versed with regulatory guidelines. Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com Kindly mention below details while sharing CV : Total Exp Current CTC Total number of ANDA/ANDS filings, Notice Period Ok for Bangalore onsite job. (5 Days working)



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