Executive Director, CMC Regulatory Affairs - Early Development
Takeda Pharmaceuticals
Takeda in Boston, MA seeks an Executive Director of Global Regulatory Affairs CMC Early Development to lead strategic CMC regulatory efforts for small molecules and biologics through Phase 2. This hybrid role emphasizes in silico modeling, data-driven approaches, and cross-functional leadership across regions. The candidate will guide global CMC strategy, ensure high-quality submissions, interact with health authorities, and drive platform approaches for accelerated programs while maintaining #J-18808-Ljbffr Takeda
$238k - $374k
...information I submit in my employment application is true to the best of my knowledge. Job Description Executive Director, Global Regulatory Affairs CMC Early Development Are you looking for a patient-focused company that will inspire you and support your career? Join us...SuggestedMinimum wageFull timeTemporary workLocal areaRemote work$238k - $374k
...to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative...SuggestedMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- ...JOB TITLE: Executive Director, Global Regulatory Affairs DEPARTMENT: Regulatory Affairs REPORTS... ...will be accountable for the development and execution of... ...product lifecycle, from early clinical development through... ...Development, Clinical Operations, CMC/Technical Operations,...Suggested
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...CMC strategy and leads the execution of regulatory CMC investigational... ...to Regulatory, Pharmaceutical Development, and Commercial project teams...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$207k - $253k
...provides strategic, tactical and operational regulatory CMC leadership to support clinical trial... ...activities of assigned projects for development and/or commercial products. Key... ...Responsibilities Independently develops and leads execution of regulatory CMC investigational,...SuggestedFull timeLocal areaFlexible hours- ...strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our... ...investigational oncology assets from early development through approval and lifecycle... ...teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations...Work at officeLocal area3 days per week
- ...The Director of Regulatory Affairs (Rare Disease) will lead global regulatory... ...strategy across multiple development programs, spanning early clinical development... ...to approval Define and execute regulatory pathways supporting... ...Partner closely with CMC, Clinical, and...
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type... ...and operational regulatory CMC leadership to support... ...of assigned projects for development and/or commercial products... ...Independently develops and leads execution of regulatory CMC...Minimum wageFull timeLocal areaFlexible hours$174.5k - $274.23k
...bring life‑changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory... ...and regulatory CMC requirements relevant to global drug development and post‑market support. Who has a proven ability to understand...Minimum wageTemporary workLocal areaRemote workWorldwide$144.4k - $195.4k
Overview The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental... ...global submissions. This position reports to the Director of Regulatory Affairs CMC, or equivalent. This position...Full timeTemporary workLocal areaFlexible hours- ...Executive Director, Regulatory Affairs About the Company Innovative biotechnology (BioTech) company specializing in precision therapies for... ...Specialties biotechnology pharmaceuticals drug development clinical development inflammatory diseases...
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology... ...pivotal role in the organization's expansion and the development of innovative products, particularly in the women's health...
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid... ...is at the forefront of development of our programs and regulatory... ...quality teams, including execution of change management and... ...experience in regulatory affairs in the pharmaceutical/biotech...Full timeTemporary workRemote workFlexible hours$212k - $333.19k
...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...will provide leadership for the development and implementation of innovative... ...strategies are implemented and project execution is on target. Evaluate new business...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift- ...Vice President, Commercial CMC About the Company Industry... ...service cell line development formulation development... ...The Company is seeking an Executive Director or Vice President for North... ...molecules while maintaining regulatory compliance and industry standards...Contract workFor contractors
- Trebla Talent is seeking an Executive Director of Regulatory Affairs for a clinical-stage biotechnology company in Boston, Massachusetts. This role provides... ...regulatory leadership primarily for late-stage development programs, including oncology initiatives. The successful...Remote work
- ...Vice President, Early Clinical Development, Radiopharmaceutical Therapies About the Company Internationally renowned biopharmaceutical company Industry Pharmaceuticals Type Public Company Founded 1858 Employees 10,001+ Categories Pharmaceuticals...
- ...leading company in pharmaceuticals is seeking an Executive Medical Director for Gastroenterology and Early R&I Clinical Development. This pivotal role requires expertise in... ...background in clinical trial design and regulatory guidelines, with an emphasis on collaboration...
- Executive Medical Director, Gastroenterology, Early R&I Clinical Development Join AstraZeneca as the Executive Medical Director, Gastroenterology, Early R&I Clinical Development... ...and patient advocacy groups. Lead regulatory communication and prepare high-level documents...Work at officeWorldwideFlexible hours
$240k - $270k
Beacon Therapeutics (USA) Inc in Cambridge is seeking an Executive Director for Technical Operations and Development. This role focuses on enhancing CMC execution for late-stage gene therapy programs, ensuring timely activity and alignment with stakeholders. The ideal candidate...Remote job$220k - $290k
...the U.S. and are exploring regulatory pathways for Europe and... ...Regulatory Leadership with the development and implementation of... ...long‑term plans. The Senior Director, Regulatory Affairs has foresight, is action oriented... ...program. Guide CMC, nonclinical and clinical...Temporary workFor contractorsWork at officeWeekday work- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle....
- ...individual will work closely with the CMC, Quality Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the successful planning, development, and delivery of CMC regulatory... ...deep expertise in CMC regulatory execution for mid‑to‑late‑stage clinical development...Flexible hours
$210k - $235k
...science, clinical development, commercial... ...geographies. The Director, Regulatory Strategy provides... ...for shaping and executing regulatory strategies... ...Clinical, Quality, CMC, Commercial, and... ...regulatory considerations early and consistently.... ...in Regulatory Affairs within the...Remote workWorldwideFlexible hours$130.8k - $209.4k
...Chemistry, Manufacturing, and Controls (CMC) function. This role, in close partnership... .... Deliver performance insights and executive-ready reporting materials highlight drivers... ...in shaping the future of our technical development areas, ensuring Moderna continues to lead...Work from homeWorldwide- ...drug discovery, clinical development, and commercialization of... ...TOLE3, which would support regulatory submissions outside the U.... ...We continue to advance an early-stage pipeline of novel therapeutic... ...the Role We are seeking a Director, Regulatory Affairs, Commercial (Advertising &...Temporary workWork at office2 days per week
$255.8k - $402.7k
Job Description The Executive Director, Chemistry, Manufacturing... ...Biologics (Biologics‑CMC) is accountable for... ...rigor in CMC regulatory strategy as well as delivery... ...the Global Regulatory Affairs and Clinical Safety:... ...GRACS, Research and Development, Manufacturing, and Global...For contractors$224.9k - $404.6k
...will be responsible for managing a team of CMC experts that prepare and oversee CMC and... ...related agency correspondence and regulatory applications. This position will oversee... ...regulatory topics is critical. Reg CMC strategy development to align with the needs of the company,...Permanent employment- ...through clinical development and successful commercialization... ...Vice President of Regulatory to lead the... ...maintenance and early‑phase clinical... ...Clinical, Nonclinical, CMC, and Quality to... ..., and advise executive leadership on regulatory... ...of regulatory affairs experience in the...
- ...pharmaceutical firm specializing in drug discovery, development, & therapeutic services Industry... ...diseases drug-discovery cmc ind enabling and drug development... ...and ensure the successful translation of early concepts into therapeutic candidates for...
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