Regulatory Affairs Specialist

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 OverviewCatalytic Data Science is revolutionizing the life sciences industry with cutting-edge AI platforms designed to enhance Regulatory Affairs Intelligence.We are seeking a skilled Regulatory Affairs Informatics Specialist to join our dynamic team. This role will be pivotal in developing AI-driven workflows that enhance the efficiency and accuracy of...

Job Title: Senior Regulatory Affairs Specialist, OperationsAbout the Role:The Senior Regulatory Affairs Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.This role will primarily support Software as a Medical Device (SaMD) and may include support for ventilators, oxygenators, and...

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: 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 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...

At Agios Pharmaceuticals, we're seeking a skilled Regulatory Affairs Strategist to join our growing Regulatory team.This individual will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.The successful candidate will prepare and oversee the...

Clinical Affairs Specialist OpportunityThis role is a key member of the business team, responsible for leading the development of evidence generation strategies for assigned projects. The Clinical Affairs Specialist will work closely with internal and external stakeholders to ensure that studies yield well-founded conclusions.Key Responsibilities:Leading the...

The OpportunityWe are seeking a seasoned regulatory affairs professional to join our growing team at Relay Therapeutics. As a strategic regulatory leader, you will play a critical role in defining and implementing innovative regulatory strategies to accelerate the development and approval of our transformative pipeline.You will serve as the global regulatory...

About UsThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.Role DescriptionWe are seeking a highly skilled and experienced Regulatory...

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 OverviewThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.We are seeking a highly skilled and experienced Head of Regulatory...

Job Opportunity at Takeda Development Center Americas, Inc.We are seeking a highly skilled Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA. As a key member of our regulatory team, you will be responsible for overseeing and executing all regulatory activities for multiple projects, including a complex project in development....

About the RoleThe Director for U.S. Advertising and Promotion will provide strategic regulatory guidance to internal stakeholders on communications related to Alnylam's marketed products, investigational treatments, and disease areas. This role will enable achievement of business objectives while ensuring compliance with U.S. laws and regulations and Alnylam...

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 SummaryThe Senior Director, US Commercial Regulatory Affairs is responsible for leading the team involved in post-marketing regulatory activities to support Ipsen's marketed products in the US. This includes prior approval submissions to FDA Office of Prescription Drug Promotion (OPDP) as required, working with Global Regulatory Labeling to review and...

About BlueRock TherapeuticsBlueRock Therapeutics is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.Job...

Job Title: Regulatory Affairs Business AnalystWe are seeking a highly skilled Regulatory Affairs Business Analyst to join our team in Cambridge, MA.About the Role:This is a Heavy Data Migration role, requiring knowledge of Regulatory, Publishing, or EDMS models. The ideal candidate will have strong interpersonal and teamwork skills, with the ability to...

Job SummaryThe Senior Director, US Commercial Regulatory Affairs will lead the development and implementation of regulatory strategies to support Ipsen's commercial operations in the US. This role will be responsible for ensuring compliance with FDA regulations and guidelines, as well as maintaining strong relationships with key stakeholders.Key...

Clinical Affairs Consultant Role OverviewThe Clinical Affairs Consultant role is a key position within our organization, responsible for leading the development of evidence generation strategies for assigned projects. This involves working closely with internal and external stakeholders to ensure that studies yield well-founded conclusions.Key...