Regulatory Affairs Manager

1 month ago


Bengaluru, Karnataka, India Biocon Biologics Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs Manager to lead our global biosimilar regulatory strategy and ensure compliance with regulatory requirements.

The successful candidate will have a strong background in drug substance manufacturing, process characterization, and regulatory strategy development.

  • Develop and execute global regulatory strategies for biosimilar products
  • Ensure compliance with regulatory requirements and approved filing plans
  • Collaborate with cross-functional teams to support product development and registration
  • Provide regulatory direction on global regulatory requirements
  • Lead regulatory compliance for biosimilar products

Key Responsibilities:

  • Develop and execute global regulatory strategies for biosimilar products
  • Ensure compliance with regulatory requirements and approved filing plans
  • Collaborate with cross-functional teams to support product development and registration
  • Provide regulatory direction on global regulatory requirements
  • Lead regulatory compliance for biosimilar products

Requirements:

  • Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) and process comparability for biologics (monoclonal antibodies/growth factors/hormones)
  • Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products


  • Bengaluru, Karnataka, India Biocon Biologics Full time

    Job Title: Manager Global Regulatory AffairsAt Biocon Biologics, we are seeking a highly skilled and experienced Manager Global Regulatory Affairs to join our team.Key Responsibilities:Develop and execute global regulatory strategies for biosimilar products, ensuring compliance with regulatory requirements and industry standards.Collaborate with...


  • Bengaluru, Karnataka, India Parexel Full time

    Director of Regulatory Affairs and Clinical TrialsWe are seeking a highly experienced Director to lead our regulatory affairs and clinical trials team.About the RoleThis is a senior leadership position that will oversee the strategic direction of our regulatory affairs and clinical trials operations.Key ResponsibilitiesProvide strategic guidance on...


  • Bengaluru, Karnataka, India Philips Full time

    Job Title: Sr. Regulatory Affairs SpecialistYou will be an integral member of our Clinical Informatics Regulatory Affairs team, influencing and shaping the regulatory capabilities for future success of Philips.Your Key Responsibilities:Ensure safe and effective products/solutions are brought to market on time and sustained throughout their lifecycle via...


  • Bengaluru, Karnataka, India Baxter Full time

    Regulatory Affairs at Baxter: A Key Role in Delivering Innovative Healthcare SolutionsBaxter, a leading medical products company, is seeking a talented Regulatory Affairs Specialist to join its team. In this crucial role, you will play a key part in ensuring the company's products meet the highest regulatory standards, enabling us to deliver innovative...


  • Bengaluru, Karnataka, India Lifelancer Full time

    Company OverviewLifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. Our mission is to connect top talent with opportunities in these fields. Job Title: Regulatory Affairs ManagerSalary: $120,000 - $180,000 per yearLocation: Remote or On-Site (Flexible)Job Description:We are seeking an experienced Regulatory Affairs...


  • Bengaluru, Karnataka, India Baxter Full time

    About VantiveVantive is a new company built on the legacy of Baxter, a leading healthcare company. We are on a mission to revolutionize kidney care and other vital organ support.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for supporting all regulatory activities...


  • Bengaluru, Karnataka, India Indegene Full time

    Job Title: Regulatory Affairs LeadAt Indegene, we are seeking a highly skilled Regulatory Affairs Lead to join our team. This role will be responsible for ensuring compliance with regulatory requirements for medical devices worldwide.Key Responsibilities:Disseminate regulatory intelligence and coordinate with stakeholders to ensure compliance.Assess...


  • Bengaluru, Karnataka, India Parexel Full time

    Unlock Your Potential in Regulatory AffairsAt Parexel, we're seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Director, you will play a critical role in ensuring the success of our clinical trials by providing expert guidance on regulatory submissions and compliance.10+ years of experience in Clinical Trial...


  • Bengaluru, Karnataka, India Parexel Full time

    About the RoleParexel is seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Consultant, you will be responsible for managing the pre- and post-approval life cycle of biologic products in various markets, including regulated (EU/US/Canada) and emerging markets.Key ResponsibilitiesDevelop and implement regulatory...


  • Bengaluru, Karnataka, India Parexel Full time

    Parexel's Regulatory Affairs Team: A Hub for ExpertiseWe're seeking a skilled Regulatory Affairs Manager to join our dynamic team, bringing experience in clinical trial regulatory submissions, managing studies, and playing regulatory leads for global trials.Regulatory Experience: Over 10 years of experience in clinical trial regulatory submissions, with a...


  • Bengaluru, Karnataka, India Parexel Full time

    Job TitleAssociate Director, Regulatory AffairsAbout the RoleParexel is seeking an experienced Associate Director, Regulatory Affairs to join our team. The ideal candidate will have a strong background in clinical trial regulatory submissions and leadership experience in managing clinical trial studies.Clinical Trial Regulatory Submissions: Over 15 years of...


  • Bengaluru, Karnataka, India Indegene Full time

    Regulatory Affairs LeadThe ideal candidate for this role will be a highly organized and detail-oriented individual with a strong background in Medical Device Regulations. As a Regulatory Affairs Lead at Indegene, you will be responsible for ensuring compliance with global regulations and facilitating the registration of medical devices.Key...


  • Bengaluru, Karnataka, India Baxter Full time

    Transforming Healthcare, One Document at a TimeBaxter is a global leader in medical innovations, and we're looking for a skilled Regulatory Affairs Specialist to join our team.As a Regulatory Affairs Specialist at Baxter, you'll play a critical role in ensuring the accuracy and compliance of regulatory documentation for our medical products.Responsibilities...


  • Bengaluru, Karnataka, India Baxter Full time

    Regulatory Role at BaxterBaxter is a leading company in the healthcare industry, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for providing regulatory support for on-market products, ensuring compliance with regulatory requirements, and identifying opportunities for process...


  • Bengaluru, Karnataka, India Biocon Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. The successful candidate will be responsible for preparing, reviewing, and submitting ANDA/ANDS in the US market, including modules.Key Responsibilities:Hands-on experience in preparation, review, and submission of...


  • Bengaluru, Karnataka, India Parexel Full time

    Unlock Your Potential in Regulatory AffairsAt Parexel, we're seeking a skilled Regulatory Affairs Consultant to join our team. As a key member of our regulatory team, you will be responsible for handling the pre and post-approval life cycle management of biologic products in various markets, including regulated and emerging markets.Key Responsibilities:8-9...


  • Bengaluru, Karnataka, India Philips Full time

    About the RolePhilips is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW.Key...


  • Bengaluru, Karnataka, India Baxter Full time

    Transforming Healthcare through Regulatory ExcellenceBaxter is a leading medical innovation company that has been pioneering significant medical breakthroughs for over 85 years. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and quality of our products and therapies.Key Responsibilities:Create and review...


  • Bengaluru, Karnataka, India ResMed Full time

    The Regulatory Affairs function at ResMed plays a crucial role in ensuring compliance with regulatory frameworks and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.Key Responsibilities:Support and maintain internal and government databases relevant to ResMed's operations.Define and...


  • Bengaluru, Karnataka, India Philips Full time

    Job Title: Principal Regulatory Affairs SpecialistJob Description:Key Responsibilities:Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead...