A company is looking for a Senior Director, Regulatory Chief of Staff.Key ResponsibilitiesManage business operations of Regulatory Affairs, including strategy, resources, and budget oversightDrive optimization of processes and lead strategic initiatives across the organizationDevelop key performance indicators and support communication strategies for Regulatory AffairsRequired Qualifications and EducationBachelor's Degree required, with at least 12 years of experience in biotech or pharmaceuticalsMinimum of 7 years leading large-scale strategic initiatives in the industryAdvanced degrees in Life Sciences or Business, with a preference for a Master / MBA in operationsOncology experience is highly preferred
Senior Director Regulatory Affairs
Due to an exciting growth trajectory, they are looking for a Senior Director Regulatory Affairs to join the leadership team at this critical time. Have established leadership experience in a senior Regulatory Affairs role. This person will head up a Global Regulatory function with the objective of e...
Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations Design Controls
Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance, with an emphasis on Design Control issues. Leadership in for the development and implementation of innovative pur...
Director, Global Regulatory Affairs, Development Strategy
Director, Global Regulatory Affairs, Development Strategy Permanent MA or MD. Proclinical is seeking a Director, Global Regulatory Affairs, Development Strategy for a global biotechnology company with locations in Massachusetts and Maryland. The Director, Global Regulatory Affairs, Development Str...
Senior Manager Regulatory Affairs and Quality Assurance
Senior Manager of Regulatory Affairs and Quality Assurance - (Medical Device) - Hybrid in MA. Our client is a growing boutique IVD and Medical Device company and they are seeking a Senior Manager of Regulatory Affairs and Quality Assurance to lead a small international team to ensure compliance with...
Executive Director/Vice President, Head of Regulatory Affairs
Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices, and provides critical risk assessments of the strategic alternatives for regulatory filings. MannKind Corporation is currently seeking an Executive Director/Vice Presid...
Associate Director, Regulatory Affairs
Independently directs as well as prepares global regulatory affairs strategies and executes regulatory activities for Syndax, with general guidance from manager and regulatory affairs leadership. Associate Director, Regulatory Affairs. Syndax has an exciting new opportunity for an Associate Director...
Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations Design Controls
Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance, with an emphasis on Design Control issues. Leadership in for the development and implementation of innovative pur...
Senior Director, Global Regulatory Lead, GI & Inflammation
Join Takeda as a Senior Director, Global Regulatory Lead, GI & Inflammation where you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates strong skills with increasing i...
Director, Global Regulatory Affairs, Development Strategy
Director, Global Regulatory Affairs, Development Strategy. Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i. Providing support to regulatory affairs reviewers...
Associate Director, Global Regulatory Affairs CMC
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. Partner with representatives of Regulatory Affairs including in-country ...