Regulatory Affairs Director

4 weeks ago


Bengaluru, Karnataka, India Parexel Full time

Unlock Your Potential in Regulatory Affairs

At 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 Regulatory Submissions
  • Proven track record of managing clinical trial studies and regulatory submissions
  • Expertise in handling the CTIS database and submitting EU CTR is desirable

Key Responsibilities:

  • Provides guidance to project team members on regulatory submissions and compliance
  • Works within broad project guidelines and facilitates issue and conflict resolutions
  • Prioritizes own workload and may prioritize the workload of the project team to achieve project scope and objectives

What We Offer:

  • Opportunities for professional growth and development
  • A dynamic and collaborative work environment
  • Competitive compensation and benefits package


  • 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 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 Lifelancer Full time

    **About Lifelancer**Lifelancer is a global talent-hiring platform that connects professionals with opportunities in the life sciences, pharma, and IT industries. Our goal is to help individuals advance their careers while promoting equal opportunities for people with disabilities. **Company Overview**Lilly is a global healthcare leader headquartered in...


  • Bengaluru, Karnataka, India Parexel Full time

    About the RoleParexel is seeking a skilled Senior Regulatory Affairs Director to lead clinical trial regulatory submissions and regulatory leadership initiatives. As a key member of our team, you will be responsible for managing clinical trial studies, serving as the regulatory lead for global trials, and providing guidance to project team members.Clinical...


  • Bengaluru, Karnataka, India Parexel Full time

    Empowering Excellence in Regulatory Affairs At Parexel, we are committed to delivering exceptional results and quality services. As an Associate Director of Regulatory Affairs, you will play a critical role in ensuring the success of our clinical trials and regulatory submissions. Key Responsibilities Clinical Trial Regulatory Submissions : Over 15...


  • Bengaluru, Karnataka, India Parexel Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Director to join our team at Parexel. As a key member of our regulatory team, you will be responsible for leading clinical trial regulatory submissions and providing regulatory leadership for global trials.Key ResponsibilitiesClinical Trial Regulatory Submissions: Over 15 years of relevant...


  • Bengaluru, Karnataka, India Parexel Full time

    About the RoleParexel is seeking a highly experienced Regulatory Affairs Director to lead our clinical trial regulatory submissions team. As a key member of our team, you will be responsible for managing global trials, ensuring compliance with regulatory requirements, and providing guidance to project teams.Key ResponsibilitiesClinical Trial Regulatory...


  • Bengaluru, Karnataka, India Parexel Full time

    About this roleWe are seeking a highly experienced Regulatory Affairs Director to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the successful submission of clinical trial regulatory documents.Key ResponsibilitiesClinical Trial Regulatory Submissions: Over 15 years of relevant experience in clinical...


  • 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 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 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 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 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

    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 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 various internal and government databases relevant to ResMed's...


  • 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

    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 Philips Full time

    Job Title: Principal Regulatory Affairs SpecialistJob Description:The Principal Regulatory Affairs Specialist will play a key role in developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW. This includes authoring 510k submissions, leading pre-sub meetings, creating...