Regulatory Affairs Specialist

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...

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...

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...

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...

Transforming Healthcare through Regulatory ExcellenceBaxter is a leading global healthcare company that has pioneered significant medical innovations 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.Your key responsibilities will include:Creating and...

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...

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...

Job Title: Global Biosimilars Regulatory Affairs SpecialistDescription:We are seeking a highly skilled Global Biosimilars Regulatory Affairs Specialist to join our team at Biocon Biologics.As a Global Biosimilars Regulatory Affairs Specialist, you will be accountable for the development and execution of CMC regulatory strategies, marketing applications, and...

Join Parexel's Team of Regulatory Affairs ExpertsJob Description:As a Senior Regulatory Affairs Associate - Labeling, you will be responsible for ensuring compliance with key labeling regulations and guidance, including CCDS, USPI, and packaging.You will have a strong working knowledge of labeling regulations and experience in label development, research,...

Job Title: Regulatory Affairs Specialist - Clinical EvidenceAbout the Role:We are looking for a highly experienced Regulatory Affairs Specialist to join our team in Stryker Global Technology Center Pvt Ltd. The successful candidate will be responsible for driving the establishment of a coherent Clinical Evidence strategy throughout the new product...

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...

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...

Vantive: Revolutionizing Kidney CareBaxter is transforming its Kidney Care segment into a standalone company, Vantive. This new entity will leverage Baxter's legacy in acute therapies and home and in-center dialysis to deliver best-in-class care to patients worldwide.As a Regulatory Affairs Specialist at Vantive, you will be part of a community driven to...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amazon Kuiper Services India Private Limited - Q38. As a key member of our Global Regulatory Affairs team, you will play a critical role in enabling and protecting our use of radio frequency spectrum and satellite orbits worldwide.Your primary responsibility will...

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...

About this role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Parexel. As a key member of our Regulatory Affairs team, you will be responsible for handling the pre and post-approval life cycle management of drug products.Key Responsibilities:Contribute to the preparation and delivery of regulatory maintenance submissions...

✅ Job OverviewGenpact is seeking a highly skilled Regulatory Affairs Specialist to join our team.The ideal candidate will possess a strong background in ECTD submissions, publishing systems, and regulatory guidelines.Key ResponsibilitiesPublishing and validating technical submissions (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian regions.Performing final...

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...

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...

At Genpact, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role demands an experienced publisher with a demonstrated ability to execute responsibility in a highly regulated and process-driven environment.The ideal candidate will have a deep understanding of eCTD types of submissions and industry-standard publishing systems....