Regulatory Affairs Director

Regulatory Affairs DirectorDyne Therapeutics is seeking a highly skilled Regulatory Affairs Director to lead the planning, management, and execution of regulatory activities for our product candidates in Europe, UK, and Switzerland.This role requires a strong understanding of EU regulatory requirements and the ability to develop and implement effective...

Job Title: Regulatory Affairs DirectorAt Dyne Therapeutics, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory strategy team, you will be responsible for driving forward our regulatory strategy and operational activities related to our muscle disease programs.The ideal candidate will have a strong...

Job Title: Head of Regulatory AffairsAbout the Role:Mural Oncology is seeking a highly experienced and strategic Head of Regulatory Affairs to lead our regulatory strategy and operations. As a key member of our leadership team, you will be responsible for ensuring the successful development and approval of our oncology products.Key Responsibilities:* Develop...

Job DescriptionDragonfly Therapeutics, Inc. is seeking a highly skilled Regulatory & Medical Affairs professional to lead our Regulatory Affairs organization.The ideal candidate will have a strong background in regulatory strategy and a proven track record of implementing innovative approaches to achieve regulatory milestones and business objectives.Develop...

Job Title: Associate Director, Regulatory Affairs CMCCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to...

Job SummaryAlkermes is seeking a highly skilled Associate Director to lead our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory strategies and guidance on post-approval CMC topics.Key ResponsibilitiesDevelop and lead regulatory CMC...

Job Description Overview: Alkermes is a global biopharmaceutical company dedicated to developing innovative treatments for complex and difficult-to-treat psychiatric and neurological disorders. We are seeking an experienced Associate Director of CMC Regulatory Affairs to join our team in Waltham, MA. Key Responsibilities:Develop and lead regulatory CMC...

Job Title: VP of Regulatory AffairsJob Summary:We are seeking a highly experienced VP of Regulatory Affairs to lead our global regulatory strategy. The successful candidate will be responsible for developing and executing comprehensive regulatory plans to ensure compliance with global regulations.Key Responsibilities:* Develop and implement global regulatory...

Job SummaryThe Vice President, Head of Regulatory Affairs is a critical leadership role responsible for developing and executing comprehensive global regulatory strategies for Innoviva Specialty Therapeutics' development programs and marketed products. This position plays a key role in shaping the regulatory pathway and ensuring compliance with global...

Job SummaryPulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. As a key member of the Pulmovant team, the Head of Regulatory Affairs and Quality will lead the global regulatory and quality strategy, providing filing expertise in all phases of development.Key...

Regulatory Manager Job DescriptionBostonGene is seeking a highly skilled Regulatory Manager to play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various...

Regulatory Affairs Project ManagerAbout the Role:We are seeking an experienced Regulatory Affairs Project Manager to join our team at BioSpace, Inc. The successful candidate will work closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and...

Job Title: Regulatory Affairs Project ManagerThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team at BioSpace, Inc. This role is responsible for facilitating timely submission of high-quality data packages to US and international health authorities. The successful candidate will work closely with cross-functional teams...

Job SummaryThe Regulatory Affairs Project Manager is a key member of the Global Regulatory Affairs team, responsible for facilitating timely submission of high-quality data packages to US and international health authorities. This role provides support to cross-functional teams, tracks and coordinates deliverables for regulatory timelines, and develops...

About the Role:Syndax Pharmaceuticals is seeking an Executive Director, Regulatory Operations to formulate and implement a regulatory operations vision and strategy for a commercial stage biotechnology company.The ideal candidate will be responsible for envisioning and implementing a fit-for-purpose Regulatory Information Management (RIM) system across...

Job DescriptionApellis Pharmaceuticals is seeking an experienced Associate Director, Regulatory Advertising to lead the development and implementation of advertising and promotional strategies that comply with regulatory requirements worldwide. The successful candidate will have a deep understanding of US and global regulations and guidelines, as well as...

Job SummaryXilio Therapeutics is seeking a highly experienced Senior Regulatory Affairs and Quality Leader to join our team. As a key member of our leadership team, you will be responsible for developing and executing global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.The ideal candidate will...

Job SummaryMythic Therapeutics is seeking a highly experienced Director/Senior Director of Regulatory Chemistry Manufacturing and Controls (CMC) to join our growing Regulatory Affairs team. This role will report to the Vice President Regulatory Affairs and will closely collaborate with Technical Operations, Quality, Clinical Operations, and other functions...

Job DescriptionDeciphera Pharmaceuticals, a biopharmaceutical company, is seeking a highly skilled Regulatory CMC Senior Manager to join its growing Post-Approval Group within the Regulatory Affairs Organization. The primary responsibility of this position is to lead and execute post-approval CMC regulatory activities in support of Deciphera's globally...

Job DescriptionBeacon Hill Life Sciences - Boston is seeking a highly organized and detail-oriented Clinical Trial Associate to support the execution of clinical trials. The ideal candidate will have a strong understanding of clinical operations and regulatory affairs.Key Responsibilities:Coordinate and manage clinical trial documents, including protocols,...