Biocon | Regulatory Affairs Specialist

4 days ago


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 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 submis sion.
Required sk ills :-
Hands on ANDA/ANDS Filing expertise.
A stable candidate from Pharma company.
Should have exp of US Submissions.
Well versed with regulatory gui delines.
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?
Ready to work in Bangalore (onsite) ? (5 Days working)

  • 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

    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...


  • 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 Biologics Full time

    At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...


  • 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 Biologics Full time

    At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...


  • bangalore, India Biocon Biologics Full time

    Job DescriptionMedical Writer for Global Medical Centre of Excellence, Patient Value & InnovationAt Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation,...


  • Bangalore Metropolitan Area, India Biocon Biologics Full time

    At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...


  • bangalore, India Biocon Biologics Full time

    About the CompanyBiocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar...


  • 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 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

    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...


  • 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 Biologics Full time

    Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across...


  • 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 Biologics Full time

    At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...


  • bangalore, India Biocon Biologics Full time

    Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across...