Regulatory Affairs Manager

About the RoleWe are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Sun Pharmaceutical Industries, Inc. This is a critical role that will play a key part in ensuring the success of our regulatory affairs function.Key ResponsibilitiesManage and coordinate global regulatory submission activities, ensuring timely and accurate...

Job SummaryClinical Resource Network (CRN) is seeking a highly skilled CMC Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory matters for investigational, new, and marketing products.Key ResponsibilitiesCMC Regulatory Strategy: Develop...

Job SummaryTaiho Oncology, Inc. is seeking a highly skilled Regulatory Affairs Operations Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing global regulatory operational activities for all Taiho Oncology, Inc. projects.Key ResponsibilitiesRegulatory Operations Management: Manage global...

Position: Senior Regulatory Affairs SpecialistLocation: Princeton, NJContract Duration: 12 MonthsExperience Required: 3-5 years in Medical Device Regulatory AffairsEssential Skills:Proficient understanding of EU MDR regulationsKnowledgeable in Regulatory Change AssessmentExperienced with US and EU medical device submission processesBackground in supporting...

Position OverviewThis role is focused on enhancing regulatory compliance within the medical device sector. The successful candidate will collaborate with various departments to refine and advance regulatory processes.Experience Requirements:3-5 years of experience in Medical Device Regulatory Affairs.Proficient understanding of EU Medical Device Regulation...

Position: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:This role involves collaborating with various departments to enhance and refine regulatory affairs processes. The specialist will support the execution of strategies and operations related to regulatory affairs, which includes overseeing the preparation of product registration...

Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the...

Position: Senior Regulatory Affairs SpecialistCompany: Intellectt IncKey Responsibilities:Engage with various departments to refine and enhance regulatory affairs methodologies.Support the execution of strategies and operations related to regulatory affairs, encompassing product registration submissions, status updates, and modifications.Revise and formulate...

Position: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview: The Senior Regulatory Affairs Specialist will play a crucial role in overseeing and enhancing regulatory processes within the organization.Key Responsibilities:Engage with various departments to refine and improve regulatory affairs methodologies.Support the execution of...

Position: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview: The Senior Regulatory Affairs Specialist will play a pivotal role in ensuring compliance with regulatory standards and enhancing operational processes within the organization.Key Responsibilities:Engage with various departments to refine and advance regulatory affairs...

Job SummaryThe Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This role will provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.Key ResponsibilitiesServe as key corporate regulatory...

About the RoleGenmab A/S is seeking a highly skilled Director/Associate Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for developing and executing global regulatory CMC strategies for biological products during early and late-stage development, and lifecycle.Key ResponsibilitiesDevelop and execute...

Job OverviewPosition: Lead Regulatory Affairs ConsultantContract Duration: 12+ monthsCompensation: Up to $115/hrKey Responsibilities:The Lead Regulatory Affairs Consultant will leverage expertise in scientific, regulatory, and commercial aspects to ensure that i-STAT branded products comply with the necessary regulations in both the US and EU.This role...

Job OverviewPosition Title: Lead Regulatory Affairs ConsultantLocation: RemoteContract Duration: 12 Month contract with potential for extension based on performanceThe role of a Lead Regulatory Affairs Consultant involves leveraging expertise in scientific, regulatory, and commercial matters to ensure that i-STAT branded products developed, manufactured, or...

Position: Senior Regulatory Affairs SpecialistCompany: Intellectt IncOverview: This role focuses on overseeing and enhancing regulatory processes within the organization.Key Responsibilities:Engage with various departments to refine and optimize regulatory affairs methodologies.Support the execution of strategies and operations related to regulatory affairs,...

Position: Senior Regulatory Affairs SpecialistLocation: RemoteDuration: Long-term ContractKey Responsibilities:This role involves collaborating with various departments to enhance and refine regulatory affairs processes. You will support the strategic implementation and operational activities related to regulatory affairs, including overseeing the...

Job OverviewKey Responsibilities:As a Lead Regulatory Affairs Consultant, you will leverage your expertise in scientific, regulatory, and commercial matters to ensure that products developed, manufactured, or distributed comply with the necessary regulations in both the US and EU.You will be recognized as a subject matter expert within your division,...

About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product...

Job OverviewPosition Title: Lead Regulatory Affairs ConsultantWork Schedule: Standard business hours, Monday to FridayROLE SUMMARY:The Lead Regulatory Affairs Consultant is responsible for integrating knowledge of scientific, regulatory, and commercial factors to ensure that i-STAT branded products developed, manufactured, or distributed by Point of Care...

Position OverviewLead Specialist in Regulatory AffairsLocation: RemoteContract Type: Long-termWe are seeking a highly skilled professional to join our team as a Lead Specialist in Regulatory Affairs. This role is crucial for ensuring compliance and facilitating the regulatory processes for our innovative medical devices.Key Responsibilities:Expertise in In...