Regulatory Operations Director

Job Title: Associate Director, Regulatory OperationsAkebia Therapeutics is seeking an experienced Associate Director, Regulatory Operations to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing all regulatory operations activities, including project submission management, Smartsheet or MS project...

Job Title: Director, Regulatory Operations Company: Ipsen Biopharmaceuticals Inc. Job Description: As a key member of the US Regulatory and Quality leadership team, the Director of Regulatory Operations will be responsible for formulating and implementing operational management strategies to create a best-in-class US regulatory operations team. This role...

Job SummaryThe Director of Regulatory Operations will be responsible for formulating and implementing operational management creating a best-in-class US regulatory operations team and technology leadership/ownership (Veeva PromoDocs) of Ipsen's Advertising/Promotion and Labeling submissions along with associated tools.This role will influence and drive US...

Job Title: Director, Regulatory Affairs, Rare DiseaseAt Ipsen Pharma, we are seeking a highly skilled and experienced Director, Regulatory Affairs, Rare Disease to join our team. This is a critical role that will be responsible for leading the development and implementation of regulatory strategies for our rare disease products.Key Responsibilities:Develop...

About the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.Job DescriptionThe Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy....

Director of Regulatory ProjectsThe RoleAs the Director of Regulatory Projects, you will provide forward-thinking leadership in overseeing strategic and operational aspects of regulatory projects across the organization. You will play a critical role as a strategic partner, guiding the development and execution of global regulatory plans that align with...

Job SummaryAs a Regulatory Affairs Director at Ipsen Pharma, you will be responsible for developing and implementing regulatory strategies for assigned programs and products. You will provide regulatory expertise to R&D, Franchise, and Commercial Operations, and act as the interface between these teams and global regulatory authorities. Your goal will be to...

Job SummaryThe Director of Regulatory Affairs will be responsible for developing and implementing regulatory strategies for assigned programs and products. This includes providing regulatory expertise to R&D, Franchise, and Commercial Operations, as well as serving as the interface between these teams and the Global Regulatory Affairs (GRA) organization.Main...

Job Title: Regulatory Affairs DirectorWe are seeking a highly skilled Regulatory Affairs Director to join our team at Proclinical Staffing. As a key member of our Commercial team, you will be responsible for providing regulatory leadership and guidance to ensure compliance with FDA regulations and industry guidelines.Key Responsibilities:Provide regulatory...

Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...

Job Title: Regulatory Affairs DirectorGlaxoSmithKline is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.Key...

Associate Director Regulatory Affairs CMC Job DescriptionWe are seeking an experienced Associate Director Regulatory Affairs CMC to join our team at PSG Global Solutions Careers. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory CMC strategies for assigned programs.Key Responsibilities:Lead...

Job Title: Associate Director, Regulatory Affairs CMCVoyager Therapeutics, Inc. is seeking an experienced Associate Director to lead our Regulatory Affairs CMC team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing global Regulatory CMC strategies to secure approval of our gene therapy products.Key...

Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in...

Job OpportunityAbout the RoleWe are seeking a highly skilled Director, Regulatory Genomics to support the advancement of genome editing products into the clinic. As a key member of our team, you will play a critical role in developing and implementing genotoxicity strategies for our in vivo and cell therapy development programs.Key ResponsibilitiesAs a...

Job SummaryONO PHARMA USA is seeking a highly experienced and skilled Director, PV Regulatory to lead our Pharmacovigilance (PV) Regulatory Affairs function. The successful candidate will be responsible for ensuring compliance with regulatory requirements, developing and implementing PV strategies, and providing expert guidance to cross-functional teams.Key...

As a key member of project teams at ONO PHARMA USA, the Associate Director, Regulatory Affairs will serve as a Health Authority liaison and establish regulatory strategies for development programs. This role is responsible for coordinating timelines, generating, and submitting complex regulatory dossiers.Key ResponsibilitiesManages the planning, preparation,...

Job Title: Director, Global Regulatory AffairsGlaxoSmithKline is seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and leadership on regulatory matters related to our RNA vaccines.Key...

Job DetailsThe Role:Moderna is seeking a seasoned professional to lead the development and implementation of global regulatory strategy for its Latent Viruses mRNA vaccines. The ideal candidate will have a strong background in regulatory affairs, with a focus on vaccine development and a proven track record of success in navigating complex regulatory...

Job SummaryWe are seeking an experienced Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will establish and communicate regulatory strategies for development programs and coordinate the timelines, generation, and submission of complex regulatory dossiers.Key ResponsibilitiesManage the planning,...