Regulatory Affairs Specialist

Regulatory Affairs SpecialistAt Parexel, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing the regulatory life cycle of drug products, from pre-approval to post-approval. Your expertise will be essential in ensuring compliance with regional regulatory...

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 been pioneering medical innovations for over 85 years. Our mission is to save and sustain lives, and we're looking for talented individuals to join our team in Regulatory Affairs.As a Regulatory Affairs Specialist, you will play a critical role in...

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...

Regulatory Affairs SpecialistBaxter is a leading healthcare company that is on a journey to separate its ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve.We are seeking a highly skilled Regulatory Affairs...

Job Title: Principal Regulatory Affairs SpecialistJob Summary:We are seeking a highly experienced Principal Regulatory Affairs Specialist to join our team at Philips. The successful candidate will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, 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...

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...

Job Title: Formulation Regulatory AffairsAt Biocon, we are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements for our formulation products in the US market.Key Responsibilities:Prepare, review, and submit ANDA/ANDS filings in the US...

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...