Executive Director, Regulatory Strategy
Confidential
Executive Director, Regulatory Strategy
About the Company
Clinical-stage biopharmaceutical company developing innovative, transformational medicines.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking an Executive Director of Regulatory Strategy to take on a pivotal role as the regulatory face of its lead program, which is in the registration stage and operates in a dynamic and competitive market. The successful candidate will be responsible for leading the regulatory strategy, solving complex regulatory challenges, and building and expanding the regulatory organization to support various global submissions. This is a unique opportunity to shape the team and its operations, particularly in the context of NDA, MAA, and other international regulatory processes. Applicants for the Executive Director of Regulatory Strategy position at the company should have a proven track record in regulatory affairs, with a focus on clinical-stage assets. The role requires a strategic thinker who can navigate the intricacies of the regulatory landscape and is adept at problem-solving in a fast-paced environment. Experience in leading and expanding a regulatory team, as well as a deep understanding of global regulatory submissions, is essential. The ideal candidate will be a visionary leader, capable of driving the regulatory function forward and ensuring the successful development and approval of innovative, transformational medicines.
Functions
- Strategy
$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per week$268.2k - $402.2k
...Vertex Pharmaceuticals seeks an experienced regulatory leader to develop and implement global regulatory strategies for Type 1 Diabetes programs. This executive role manages a team of regulatory professionals across multiple development stages and represents regulatory...Suggested$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ...Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs, and as an expert...SuggestedPermanent employmentFull timeWork at officeWork from home$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director 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...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$185.6k - $278.4k
Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of... ...meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG).Plan and... ...(e.g., US, EU, GB, CA).Lead labeling strategy with expert ability to advise stakeholders...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and as an expert...Permanent employmentFull timeWork at officeWork from home$177k - $278.08k
...changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ....In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific...Minimum wageLocal areaRemote workWorldwide$235k - $335k
...heard.How you’ll make an impact:Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the company's first dedicated... ..., and partner across Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and business challenges...- ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing... ...and regulatory recommendations to executive management. Proactively informs AST and cross...Temporary workWorldwide
$185k - $315k
...to create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all.The Executive Director, Specialty Commercial Strategy will lead the commercial strategy and business performance of athenahealth’s specialty growth initiative. This...Full timeTemporary workWork at office$271.2k - $406.8k
...in the Fenway area of Boston, Massachusetts.SummaryThe Executive Director, Commercial Strategy & Execution will lead strategic portfolio or country-... ...Insights & Analytics, R&D, Market Access, Marketing / Sales, Regulatory Affairs, Finance, and Medical Affairs) for the...Work experience placement$231.9k - $365k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation... ...clear, timely, and robust strategies for registration enabled by engagement... ...professionalism.Position Description:The Executive Director, Regulatory Affairs Liaison reports to...Full timeFor contractorsLocal areaWorldwideFlexible hours- ...Executive Director, Specialty Commercial Strategy About the Company Top healthcare IT solutions company Industry Information Technology and Services Type Public Company Founded 1997 Employees 5001-10,000 Categories Enterprise Software...
- A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience in regulatory affairs, particularly in oncology, to ensure alignment between US and...
- ...Biogen is seeking an Executive Director of Development Asset Leadership to accelerate scientific promise into patient impact by shaping strategy, execution, and success across a diverse portfolio of therapies. You will lead Development Asset Leads and collaborate with...
- ...The Executive Director Marketing Strategy & Partnerships serves as a senior leader and primary connection between Boston University's schools, colleges, and administrative units and the External Affairs division. This role collaborates across the institution to define...Full timeFor contractorsCasual workWork at officeFlexible hoursNight shift3 days per week
$294k - $318k
Department: 1310US - Regulatory - USLocation: Waltham, MACompany Overview:Dyne Therapeutics... ...and Facebook.Role Summary:The Executive Director, Regulatory Affairs serves as a visionary... ...who shapes long-term program regulatory strategy, collaborates on regulatory functional...Local area$224.9k - $404.6k
...of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead and support all regulatory activities to provide...Permanent employmentFull timeWork at officeWork from home- ...in the United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure... ...guidelines. This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex...
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA...
$290k - $323k
...follow the Company on LinkedIn and X. Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through... ...Proactively identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management,...Temporary workFor contractorsFlexible hours- ...Director-level regulatory affairs position leading global strategy development and market approval efforts for neuroscience products. Responsible for managing cross... ...regulatory assessments and recommendations to executive management and senior stakeholders Requirements...
$218.06k - $327.09k
...role: Are you ready to set the global regulatory vision for pioneering cell therapies... ...approval and labeling. You will shape strategy for complex, visible programs,... ...for patients. You will report to the Executive Director, Cell Therapy Regulatory Affairs and act...Hourly payTemporary workStart working todayWork at officeFlexible hours3 days per week$267.91k - $401.87k
...AstraZeneca seeks a Strategy and Commercial Executive Director to lead end-to-end cell therapy strategy for defined indications, driving commercial initiatives and competitive intelligence across the Cell Therapy Enterprise. The role requires shaping portfolio strategy...$170k - $215k
...with 250+ employees world-wide.As Director of Site Performance & Strategy- Cardiology at Iterative Health, you... ...—including pre-screening, regulatory support, and eSource—you will partner... ...screening, and eSource.Own the design, execution, and continuous improvement of the...Temporary workWork at office2 days per week- ...Therapeutics seeks its first dedicated AI leader to define and execute enterprise AI strategy across the organization. Reporting to the VP of... ...build, and deploy AI solutions across research, development, regulatory, and operations Evaluate, select, and administer AI platforms...
$267.91k - $401.87k
...progressing a broad pipeline of cell therapies in collaboration with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director , Cell Therapy Strategy and Commercial (CTSC), is a high-impact leadership role accountable for shaping and...Temporary workWork at officeFlexible hours3 days per week- ...Rapport Therapeutics seeks an Associate Director of Regulatory Strategy to develop and execute regulatory pathways for a small-molecule neuromedicine pipeline. This Boston-based role involves cross-functional collaboration, regulatory authority engagement, and strategic...
- ...neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn. Summary of Position: The Associate Director, Regulatory Strategy, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or...Shift work
- ...Tango Therapeutics seeks an Executive Director to lead commercial strategy and portfolio initiatives, driving launch readiness and cross-functional collaboration... ...across commercial, supply chain, manufacturing, regulatory, and finance teams Requirements ~ Bachelor's...
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