Strategic Director Global CMC Regulatory Affairs (Hybrid)
Vertex Pharmaceuticals LLC
Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization. Hybrid work options are available, with emphasis on strategic leadership and digital regulatory capabilities. The candidate will guide dossier preparation, drive process improvements, and foster cross-functional collaboration in a #J-18808-Ljbffr Vertex Pharmaceuticals LLC
- ...Manufacturing Controls Manager to lead regulatory CMC activities for investigational and commercial... ...will review CMC submissions, develop global regulatory CMC strategies, and serve as... ...functional teams and Health Authorities. A hybrid work arrangement is available, with on-...Suggested
$211.5k - $258.5k
...fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is... ...of the Regulatory Affairs team, this individual... ...& Location Hybrid - This position follows... ...document development, strategic meeting preparation,... ...alignment with clinical, CMC, and non‑clinical...SuggestedLocal areaFlexible hours2 days per week$187k - $253k
...Overview:The Director of Technical Operations and Quality (TOQ) Strategic Sourcing has responsibility for... ...modalities.This position is hybrid and will be primarily... ...leaders across R&D, CMC, and Quality to influence... ...other peers within the Global Strategic Sourcing organization...SuggestedFull timeContract workTemporary workLocal areaFlexible hours$200k - $265k
...impact.The OpportunityLeads the global regulatory strategy, submission... ...Accountable for the Global Regulatory Affairs team supporting nemolizumab... ...and commercial teamsEnsure strategic regulatory input is provided... ...clinical, non-clinical, and CMC development documentation as...SuggestedFull timeTemporary workWork experience placementWork at officeWorldwide- EY-Parthenon is seeking a Director to lead Strategy and Execution in Restructuring, working with CEOs and Boards to optimize liquidity,... ...client leadership, and collaboration across EY-Parthenon sub service lines in a hybrid U.S. environment. #J-18808-Ljbffr EY-ParthenonSuggested
- ...Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for... ...strong understanding of regulatory affairs frameworks and a minimum of 8... ...of submissions. Vertex offers a hybrid work model and a comprehensive benefits...
- Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-... ...development through post-marketing. This role supports hybrid in-office engagement amid relocation plans to...Work at officeRelocation
- ...stakeholders. This role is hybrid in either Cambridge, MA... ...Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional... ...Label Profiles. Provide strategic guidance to Core... ...in fields of Regulatory Affairs, Pharmacovigilance, and...Local area
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory strategy for biologics assets from early development... ...CMOs to ensure alignment with FDA/EMA expectations and global regulatory standards. As a senior leader, you will drive...
- ...candidate will have a Bachelor's Degree and 1-2 years of experience in program management, strong communication skills, and a passion for global health and social justice. This is a hybrid position located in Boston, MA. #J-18808-Ljbffr Center for Integration Science
- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA... ...authority interactions, and lifecycle management. Hybrid work with on-site days is expected, and the candidate...
$285k - $310k
...should have 15+ years of experience in valuation or fund accounting, with expertise in US GAAP and proven leadership abilities. This hybrid position also offers a competitive salary ranging from $285,000 to $310,000, alongside an annual bonus and comprehensive benefits....- ...leader to run end-to-end program management for high-value regulatory and strategic initiatives. You will guide cross-functional teams across analytics... ..., and seamless post-acquisition integration, with a mix of hybrid-eligible work arrangements and a strong emphasis on...
$212k - $318k
...than ever before.The Director, T1D will serve as a T... ...CGT) portfolio in the Global Value and Access Strategy... ...:Lead payer strategic planning to ensure value... ...International P&R, Corporate Affairs, US Managed Markets,... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workRemote workFlexible hours2 days per week$128.55k - $222.82k
...The Director, Global Wellbeing is a member of the Global Pension, Benefits... .... The Director provides strategic leadership, governance, program... ...comply with applicable legal, regulatory, and privacy requirements.... ...future you want to see. #LI-Hybrid The role being advertised...Full timeTemporary workLocal areaFlexible hours- Senior Director, Program Leader, Corporate... ...through regulatory approval, launch... ...fully integrated global asset strategy... ...mindset in all strategic decisions. Cross... ...with Regulatory Affairs to guide global... ...strategy, CMC, medical affairs... ...Location This role is Hybrid, requiring some...3 days per week
$153k - $185k
DescriptionWhat We’re Looking ForWe’re looking for a strategic and creative brand leader to shape how Meltwater shows up around the world.As Director, Global Brand Strategy, you’ll be the strategic... ....Energetic work environment with a hybrid work style, providing the balance you...Local areaFlexible hours$145.6k - $218.4k
...As the Associate Director of Strategic Sourcing for Cell and... ...This role requires a hybrid work schedule: 3 days... ...business outcomes. Global Category Management -... ...quality, technical, regulatory, and service expectations... ...Supply Chain, Regulatory Affairs, Finance, Legal, and...Long term contractFull timeContract workSummer workWork at officeRemote workFlexible hours2 days per week$212k - $333.19k
...? Join us as a Senior Director, Global Program Leader - Oncology... ...driving regulatory approval as well as launch... ...Provides matrix management, strategic and tactical leadership... ...Pharmaceutical Sciences (CMC) Subteam, etc. to the... ...classified as “hybrid” in accordance with Takeda...Minimum wageTemporary workWork at officeLocal areaRemote workNight shift- ...Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is... ...(GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May...Temporary workWorldwide
- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and... ...industry, with strong knowledge of regulatory requirements. Opportunities for hybrid work are available. #J-18808-Ljbffr...
- ...of Education (HGSE) seeks an Associate Director of Development to raise flexible gifts supporting... .... The position emphasizes autonomy, strategic prospect planning, and the ability to... ...targets and multi-year commitments. Hybrid schedule and travel are required as part...Flexible hours
- ...locates its world headquarters in Boston, MA, seeking a dynamic Director of Strategic Sourcing for Small Molecules. The role leads the sourcing... ...improvement across materials and services, with a hybrid/onsite work model and travel as needed. #J-18808-Ljbffr Vertex...
- Hasbro is seeking a Compensation Director to lead the Global Total Rewards compensation function. You will shape the global pay philosophy, oversee programs, and collaborate with executive leadership, HR, Finance, and Legal to ensure market-competitive compensation across...
- Crocs, Inc. seeks a Director of Product Development - Materials to lead an end-to-end materials strategy across Product Development, Design, Sourcing, and global teams. You will build a materials-first operating model, translate trends into actionable material direction...
$212k - $333.19k
...through life-changing work. Certified as a Global Top Employer, we offer stimulating... ...seeking a highly motivated, insightful, and strategic leader to join the Global Insights & Analytics... ...position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote...Minimum wageTemporary workLocal areaImmediate startRemote work$230k - $330k
...Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed... ...Overview The Head of Global Strategic Sourcing is responsible for establishing... ...Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing...Full timeWork at office- ...Summary:The Project Management & Strategic Operations Director serves as the end-to-end program lead... ...of high business value within Global Regulatory Affairs (GRA). Drives benefit achievement... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility...Full timeSummer workRemote workFlexible hours2 days per week
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
$189k - $246k
Travere Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase 3 drug development programs. As the regulatory lead, you will ensure compliance,...Remote job
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