Executive Director, Global Regulatory Affairs CMC Early Development
Takeda Pharmaceutical Company Ltd
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all 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 as Executive Director, Global Regulatory Affairs CMC Early Development (GRA CMC ED). Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Executive Director, GRA CMC Early Development, you will provide strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development. You will champion fit-for-phase CMC a...Regulatory Affairs, Director, Development, Executive, Regulatory, Global, Business Services
- ...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 as Executive Director, Global Regulatory Affairs Cmc Early Development (Gra Cmc Ed). Here, everyone...Suggested
- ...Job Description As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit‑for‑phase regulatory strategies for small molecule...SuggestedTemporary workLocal area
$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- Takeda Pharmaceuticals International GmbH is seeking an Executive Director, Global Regulatory Affairs CMC Early Development in Cambridge, Massachusetts. This role involves delivering innovative global regulatory strategies for drug development while ensuring compliance...Suggested
$154.4k - $242.55k
.... This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ..., develops and leads the execution of regulatory CMC investigational... ...Regulatory, Pharmaceutical Development, and Commercial project teams...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...
$137k - $215.27k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,... ...some supervision, leads the execution of regulatory CMC... ...at Regulatory, Pharmaceutical Development, and Commercial project teams...Minimum wageFull timeTemporary workLocal 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,...
$170.9k - $231.3k
## Associate Director, Regulatory Affairs, CMCUnited StatesApply NowFind... ...Regulatory Affairs CMC Development is responsible for... ...and implementating global CMC regulatory strategies... ...the development and execution of global CMC... ...complex modalities across early- and late-stage...Full timeTemporary workWork at officeLocal areaFlexible hours- ...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...
- A global pharmaceutical organization... ...expanding its regulatory leadership team and seeking a Director, Global Regulatory Affairs to provide strategic... ...or more drug development programs. This... ...regulatory strategy, executional oversight, and... ...spanning early development through...Local area
- ...editing through the development of SyNTase™ editing,... ...Reporting to the Head of Regulatory Affairs, you will work... ...patients. As the Regulatory CMC lead for these... ...collaboration with CMC and global development teams,... ...accomplishments: ~ Associate Director: ~12+ Years of...Contract workRemote work
- ...leadership role for the development of the Zugo-cel CAR-T... ...to the Head of Regulatory Affairs, you will work closely... ...patients. As the Regulatory CMC lead for these... ...collaboration with CMC and global development teams,... ....Regulatory Affairs, Director, Regulatory,...Contract work
$211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...Hourly payTemporary workWork at office3 days per week$352k
...Join Takeda as a Head of Global Regulatory Affairs – Oncology where you will provide... ...clinical aspects of drug development and associated regulations.... ...as primary advisor to executive leadership. Full portfolio... ...to‑end accountability from early development through commercialization...Minimum wageTemporary workLocal area- ...Senior Vice President Global Regulatory Affairs. Their approach is... ...seasoned regulatory executive to lead our global regulatory... ...toward late‑stage development. The SVP, Global... ...regulatory strategy spanning early development through... ...with Clinical, CMC, Biomarker, Program Management...
- ...The Director of Regulatory Affairs (Rare Disease) will lead global regulatory strategy across multiple development programs, spanning early clinical development through to BLA... ...approval Define and execute regulatory pathways... ...Partner closely with CMC, Clinical, and Nonclinical...
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime... ...regulatory CMC leadership to support... ...assigned projects for development and/or commercial... ...develops and leads execution of regulatory CMC investigational... ...topics.* Provides global regulatory input and...Minimum wageFull timeLocal areaFlexible hours$144.4k - $195.4k
Overview The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental programs. This role... ...submissions. This position reports to the Director of Regulatory Affairs CMC, or equivalent. This...Full timeTemporary workLocal areaFlexible hours- ...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a... ...developing and executing regulatory... ...background is preferred. CMC experience is a... ...assigned programs from early development...
$177k - $278.08k
...therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for... ...regulatory guidance for the global development of various products within the Neuroscience... ...regulatory strategy is updated and executed, ensuring global regulatory...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Takeda seeks a Director Regulatory Site CMC in Boston, MA, responsible for managing regulatory change control and ensuring compliance with global standards. The ideal candidate will have over 10 years of biopharmaceutical industry experience, including significant knowledge...
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown... ...at the forefront of development of our programs and... ...a goal to develop global regulatory CMC... ...quality teams, including execution of change management... ...experience in regulatory affairs in the...Full timeTemporary workRemote workFlexible hours$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... ...degree in a scientific discipline. Responsibilities include executing regulatory strategies and managing submissions. The...$177k - $278.08k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management... ...strong practical experience with global HA requirements, beyond EU/US. who... ...requirements relevant to global drug development and post-market support. Who has a proven...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company... ...organization's expansion and the development of innovative products,... ...regulatory activities. This includes global regulatory strategy, managing health...
- Trebla Talent is seeking an Executive Director of Regulatory Affairs for a clinical-stage biotechnology company... ...leadership primarily for late-stage development programs, including oncology... ...The successful candidate will guide global regulatory strategies and collaborate...Remote work
- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing... ...and advising on global Regulatory CMC... ...regulatory strategy for CMC development of gene therapy... ...project teams in early research and all stages... .... Design and execute an effective global...
- ...President, Commercial CMC About the Company... ...service cell line development formulation development... ...is seeking an Executive Director or Vice President for... ...molecules while maintaining regulatory compliance and... ...Title SVP, Head of Global CMC Travel Percent...Contract workFor contractors
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