Regulatory Operations Director

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 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 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...

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 OpportunityThe Role:Moderna is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRNA vaccines. This role is intended for a forward-thinking, creative regulatory strategist able to anticipate and address challenges in clinical development and gain market approval for mRNA vaccines.The Director will be a strategic leader...

Regulatory Labeling DirectorWe are seeking a highly skilled Regulatory Labeling Director to join our team at BioSpace, Inc. This is a unique opportunity to leverage your expertise in regulatory labeling to drive the success of our respiratory franchise products.Key Responsibilities:Develop and maintain current knowledge of labeling regulations and industry...

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 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 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...

Job DetailsThe Role:As a key member of our Global Regulatory Science team, we are seeking a Director of Global Regulatory Strategy to develop and lead the global strategy for our mRNA vaccine programs. The ideal candidate will have a strong background in regulatory strategy, particularly in vaccine development, and will be able to articulate clear and...

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...

About the RoleWe are seeking a highly skilled Senior Director, Global Regulatory Lead, GI to join our team at Takeda. As a key member of our organization, you will be responsible for defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Key...

About the Role:We are seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team at Takeda. As a key member of our Regulatory Affairs CMC team, you will be responsible for establishing collaboration with Global CMC teams and leadership through networks and enabling CMC regulatory team's success in meeting goals/objectives.Key...

Job DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...

The Opportunity:Moderna is seeking a Director of Regulatory Strategy to lead the development and implementation of global regulatory strategy for our Latent Viruses mRNA vaccines. As a key member of our Global Regulatory Science team, you will be responsible for articulating clear and compelling regulatory strategy, highlighting risks and opportunities, and...

Job Summary:The Director of External Manufacturing Operations at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API), drug products, and primary packaging. This leader...

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...

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...

Job Title: Associate Director Data OperationsWe are seeking a highly skilled Associate Director Data Operations to join our team at Randstad. This is a contract position based in Cambridge, Massachusetts, with a salary range of $56.47 - $74.99 per hour.Job Summary:The Associate Director Data Operations will be responsible for supporting Digital Health...