Strategic Regulatory Affairs Director

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...

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 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 SummarySun Pharmaceutical Industries, Inc. is seeking a highly experienced and skilled Regulatory Affairs Leader to join our team as Senior Director, Regulatory Affairs Strategy. This is a key leadership role that will provide strategic direction and guidance on regulatory affairs for our novel drug development programs.Key ResponsibilitiesDevelop and...

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...

Position OverviewOur esteemed client in the pharmaceutical sector is in search of a Director of Regulatory Affairs for Chemistry Manufacturing & Controls (CMC). This role is pivotal in steering global teams through the intricacies of regulatory strategy and the formulation of CMC elements within drug development initiatives. Collaboration with various...

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...

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...

About the RoleWe are seeking a highly experienced and skilled Executive Director to lead our Regulatory Affairs team in Precision Medicine & Digital Health. As a key member of our organization, you will be responsible for developing and executing global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital...

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 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...

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 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,...

Home Search Jobs Job Description Senior Regulatory Affairs Specialist Contract Type: Contractual Position Salary: $100.00 Per Hour Job Code: N/A Industry: Medical Device Location: Remote Duration: 12 months (with potential for extension) Key Responsibilities:Prepare, compile, and review regulatory submissions for both US and EU markets. Proactively...

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 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...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Labeling Associate to join our team at SPECTRAFORCE. As a key member of our team, you will be responsible for supporting our clients' business by preparing and reviewing regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation, and client internal...

Job OverviewPosition Summary: The individual in this role will be accountable for the preparation and upkeep of US 510k submissions and EU IVDR Technical Files, ensuring adherence to relevant Corporate and Divisional Policies and quality system protocols.Key Responsibilities:Compile, prepare, and evaluate regulatory submissions for both US and EU...

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...

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...