Senior Director, Regulatory Affairs

This clinical-stage company is advancing innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and execute on global regulatory strategies for an early-stage Rare Disease program. In this role, you will work closely with cross-functional teams and Health...

Position Summary This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity...

Job Title: Associate Director, Global Regulatory AffairsTakeda Development Center Americas, Inc. is seeking an experienced professional to fill the role of Associate Director, Global Regulatory Affairs in Cambridge, MA.Responsibilities:Lead the development of high-level global regulatory strategies for late-stage development projects.Provide global...

About the Job The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment options for...

About the RoleThe Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, developing regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer...

Senior Director, Regulatory Strategy Job Description General Summary: The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory...

Senior Director, Medical Affairs (Medical and Scientific Ops) Boston, MA, USA Req #235 Thursday, March 7, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with...

About the JobThe Senior Specialist, Regulatory Affairs will play a key role in supporting the regulatory submissions process by developing regulatory strategy and submitting materials to health authorities, such as the FDA, for the approval of novel platforms. This position will provide regulatory guidance to internal development teams and prepare document...

Director, Global Regulatory Affairs, Development Strategy This is what you will do: Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.You will be responsible for: Developing and...

At MannKind, our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.Position Summary:MannKind Corporation is currently...

Job Summary: We are seeking a highly skilled Senior Manager to lead our Regulatory Affairs team in the development and implementation of regulatory strategies for diagnostic products. The ideal candidate will have a strong background in regulatory affairs, with experience in managing complex projects and developing regulatory strategies for medical devices...

Director/Senior Director, Regulatory Strategist – Global Regulatory Lead (Hybrid) Position SummaryPepGen is at an exciting time in our development. Reporting into the SVP Head of Regulatory, you will be responsible for the global regulatory strategic development for one of our lead assets, providing a unique opportunity for a motivated and team-orientated...

Head of Regulatory Affairs About the Company Innovative biotechnology (BioTech) portfolio IndustryBiotechnology TypePrivately Held About the Role The Company is in search of a Head of Regulatory Affairs to take on a pivotal role in leading strategic regulatory decisions for its innovative biotech portfolio. The successful candidate will be a core member of...

Vice President, Regulatory Affairs About the Company Excelling biotechnology (BioTech) company IndustryBiotechnology TypePrivately Held Founded2017 Employees201-500 Categories BiotechnologyB2BHealth CareMedicalTherapeuticsPharmaceuticalsMedicineManufacturingChemical Products Specialties cancerpharmaceutical researchfunctional genomicsdrug discoveryand...

Head of Regulatory Affairs About the Company Pioneering biopharma company IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a Head of Regulatory Affairs to take on a pivotal leadership role in shaping the future of the organization. The successful candidate will be responsible for leading the development and execution of...

Vice President Regulatory Affairs About the Company Pioneering biopharma company IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a VP of Regulatory Affairs to take on a pivotal leadership role in shaping the future of the organization. The successful candidate will be responsible for leading the development and execution of...

Job Title: Head of Regulatory Affairs-CMCJob Summary:Ironwood Pharmaceuticals seeks a seasoned Regulatory Affairs expert to lead our CMC function, ensuring compliance with global health authority regulations and guidelines. As Head of Regulatory Affairs-CMC, you will develop and execute a strategic regulatory plan to support product development and...

About the Job The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through the development of regulatory strategy and submission of materials to health authorities such as FDA for the approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares...

This is what you will do: Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.You will be responsible for: Job Duties and Responsibilities Provide CMC support and...

Head of Global Labelling, Regulatory Affairs About the Company Well-established pharmaceutical company IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a Head of Global Labelling in Regulatory Affairs to join their team. This senior leadership role is pivotal in providing expert regulatory knowledge and strategy for the...