Formulation Regulatory Affairs Specialist

4 months ago


bangalore, India Biocon Full time

Key ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.Publishing the necessary regulatory dossiers into eCTD format as per the country requirement.Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received.Responsible to understand the requirements related to US regulatory submissions.Qualification: M.Pharm/B.PharmExperience: 8 Years to 12 Years



  • 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 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...


  • 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...


  • 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 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...


  • 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 Modules. Experience and...


  • bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Exp:Experience Req.: 9 - 14 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...


  • Bangalore, India Biocon Full time

    Key Responsibilities Preparation, review, and timely submission of ANDA in US market. Deficiency and life cycle management for the products filed in US. Review of technical (developmental and plant) documentations required for dossier submission. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO...


  • Bangalore, India Biocon Full time

    Key Responsibilities Preparation, review, and timely submission of ANDA in US market. Deficiency and life cycle management for the products filed in US. Review of technical (developmental and plant) documentations required for dossier submission. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO...


  • bangalore, India Biocon Full time

    Key Responsibilities Preparation, review, and timely submission of ANDA in US market. Deficiency and life cycle management for the products filed in US. Review of technical (developmental and plant) documentations required for dossier submission. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects)...


  • bangalore, India Biocon Full time

    Key ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...

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