Global Regulatory Lead

Job Description:The Director of Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in assigned therapeutic areas.Key Responsibilities:Leads the Global Regulatory Product Team (GRPT) to develop creative global strategies in line with applicable regulations to achieve...

Job Title: Regulatory Affairs DirectorJob Summary:We are seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and ensure compliance with regulatory requirements. The successful candidate will have a strong background in pharmaceutical industry experience, with a focus on regulatory affairs leadership roles.Key...

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...

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...

Role OverviewGSK Oncology is committed to the discovery and development of new oncology therapies with the potential to improve patient outcomes.As a Global Statistical Lead, you will provide statistical support in non-registrational data generation, secondary publications, and scientific congress support to deliver clearly differentiated medicines to our...

The role of Global Medical Affairs Operations Lead at CSL Behring is a senior position that requires a high degree of expertise in medical affairs operations. Reporting directly to the Executive Director, this individual will be responsible for overseeing the implementation of changes and innovations to support the transformation project in Medical...

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...

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 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 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 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 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...

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...

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 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...

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 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 IT Validation LeadDyne Therapeutics Inc is seeking an experienced Associate Director IT Validation Lead to lead the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments.This role focuses on the development,...

Job SummaryThe Associate Director of IT Validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments.This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems...