CMC Regulatory Director - AI-Driven Global Strategy
Vertex Pharmaceuticals
Vertex Pharmaceuticals in Boston seeks a Director, CMC to lead global regulatory strategies for the small molecule portfolio, overseeing submissions and Health Authority interactions. The role drives governance, mentors Regulatory CMC staff, and champions AI-enabled capabilities to improve content quality, decision-making, and efficiency across development and commercialization plans. #J-18808-Ljbffr Vertex Pharmaceuticals
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...Suggested
- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...Suggested
- ...seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You... ...partner with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while...SuggestedRemote work
- ...Pharmaceuticals in Cambridge, MA seeks a senior executive to lead global strategic sourcing, supplier management, and third-party... ...a Finance Leadership Team member, you will shape category strategies, drive AI-enabled procurement, and partner with R&D, Technical Operations...Suggested
$200k - $265k
...direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health... ...including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge... ...Galderma, you’ll be part of a purpose-driven organization committed to advancing...SuggestedFull timeTemporary workWork experience placementWork at officeWorldwide- Vertex is a global biotechnology company seeking an Associate Director in CMC to lead global regulatory strategies for biologics, authoring and reviewing submissions, and serving as the... ...Health Authorities. The role emphasizes AI-enabled regulatory document preparation and...
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early-stage... ...II. You will collaborate with Clinical Development, CMC, Non‑Clinical Sciences, and Bioanalytics to drive IND/CTA...
$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ...background is preferred. CMC experience is a plus.ResponsibilitiesDevelop...$137k - $215.27k
...to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...investigational, registration and/or post-approval strategies for assigned products.RA CMC member on the...Minimum wageTemporary workLocal areaRemote workWorldwide- ...Moderna, Inc. is seeking a Director of Regulatory Strategy to lead regulatory plans for select programs in rare, autoimmune, and oncology portfolios. This role requires strategic leadership within Global Regulatory Science to address challenges in gaining market approval...
$238k - $374k
...to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products...Minimum wageTemporary workLocal areaRemote work$238k - $374k
...changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will... ...matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...Remote jobPermanent employmentContract work
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...
- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
- Vertex Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed products. The ideal candidate will have a strong understanding of regulatory affairs frameworks...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall...Local areaFlexible hours2 days per week- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities...
- Eli Lilly and Company seeks a Director/Senior Director, Regulatory CMC to lead regulatory CMC strategies for our gene therapy portfolio, guiding from development through... ...as the main liaison with health authorities globally. This role requires 5+ years in regulatory CMC...
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations... ...Are you ready to set the global regulatory vision for pioneering... ...objectives with clinical, CMC, safety and commercial... ...to enable decisive, data-driven choices.Delivery and Milestone...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...Permanent employmentFull timeWork at officeWork from home$212k - $318k
...plans across the lifecycle. We are driven by a desire to deliver groundbreaking... ...patients faster than ever before.The Director, T1D will serve as a T1D Market... ...Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be responsible...Full timeSummer workRemote workFlexible hours2 days per week$168k - $199k
...the intersection of strategy, technology, and... ...responsible for shaping AI strategy, guiding... ...deployments. The Director operates as a... ...privacy, security, regulatory alignment.Stay ahead... ...20,000 associates globally who support over 1... ...How far you go is driven by your passion...Full timeRemote workWorldwide$163.5k - $281.6k
...work worth doing. If you’re driven by purpose and ready to bring... ...experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy... ..., ensuring compliance with global health authority...For contractorsWork at officeFlexible hours$182k
...@abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. ( Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market...Local areaWorldwide$189k - $246k
...Department: 107000 Regulatory Location: San... ...Remote Be a part of a global team that is... ...Position Summary: The Director, Regulatory Affairs Strategy is responsible for developing... ..., Biostatistics, CMC, Quality,... ...Focus and Teamwork Driven, intelligent, passionate...Temporary workLocal areaRemote workWeekend work
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