Formulation regulatory affairs

3 weeks ago


Bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Assistant Manager / Deputy Manager /Associate Manager - US Market Required Education/Exp: Experience Req.: 7 - 12 yrs. Qualification: - M. Pharma / M. Sc. 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 e CTD 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 :- 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 :- Kindly mention below details while sharing CV : Total Exp? Current CTC? Total number of ANDA/ANDS filings? Handling Pre-approval activities or not? Notice Period Ok for working in Bangalore? (5 Days working)



  • Bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M. Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including...


  • bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Assistant Manager / Deputy Manager /Associate Manager - US MarketRequired Education/Exp:Experience Req.: 7 - 12 yrs.Qualification: - M. Pharma / M.Sc.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...


  • bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Deputy Manager /Associate Manager/ Manager - US MarketRequired Education/Ex p:Experience Req.: 9 - 14 yrs.Qualification: - M. Pharma / M. Sc.Responsibiliti es:Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge...


  • Bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M. Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including...


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    Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M.Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and...


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    Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M.Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and...


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