Regulatory Submission Specialist

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....

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...

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...

Regulatory Support Specialist Role OverviewBaxter is on a journey to separate our kidney care segment into a standalone company. Vantive will build on our legacy in acute therapies and home and in-center dialysis to provide best-in-class care to our patients.This role is responsible for providing regulatory support for on-market products. The Specialist will...

Parexel seeks a dedicated Regulatory Affairs Specialist to support the life cycle management of biologic products in regulated and emerging markets.Key Responsibilities:8-9 years of experience in handling pre and post-approval life cycle management of biologic products in various markets (EU/US/Canada) and emerging markets.Good understanding of regulatory...

✅ 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 SummaryWe are seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our publishing team, you will be responsible for managing submissions, planning submission workloads, and partnering with regulatory associates to retrieve, publish, and submit regulatory documents.Key ResponsibilitiesManage submissions,...

Job SummaryWe are seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our Regulatory Affairs department, you will be responsible for managing submissions, coordinating global registration activities, and ensuring compliance with regulatory requirements.Key ResponsibilitiesManage submissions, including...

We're seeking a skilled Regulatory Publishing Specialist to join our team at Lilly.Key Responsibilities: Manage submissions, including preparing submission cover letters and forms, and planning submission workloads. Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic...

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...

We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our Regulatory Publishing team, you will be responsible for managing submissions, planning submission workloads, and partnering with regulatory associates to retrieve, publish, and submit modules 1-5 reports/documents and combine files into...

We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly.Key Responsibilities:• Manage submissions, preparing cover letters and forms for regional review and approval.• Plan submission workload by reviewing the RDE RIM or Share Point Calendar for planned documents.• Partner with the Regulatory Associate to retrieve,...

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...

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...

As a Regulatory Labelling Specialist at Biocon Biologics, you will be responsible for creating and implementing labelling strategies for health authority interactions and handling queries from country organizations. You will work closely with the CFT team to ensure artwork management for initial submissions and commercial launches.Key responsibilities...

Clinical and Regulatory Submissions Medical WriterAt ClinChoice, we are seeking a highly skilled Medical Writer to join our team.About the RoleThe Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update...

Clinical Documentation SpecialistAt ClinChoice, we are seeking a highly skilled Clinical Documentation Specialist to join our team. As a key member of our medical writing team, you will be responsible for creating, editing, and coordinating the production of clinical and regulatory submission documents.Key Responsibilities:Research and create clinical...

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: 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...

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...