Strategic Director Global CMC Regulatory Affairs (Hybrid)
Jobleads-US
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 Jobleads-US$187k - $253k
The Director of Technical Operations and Quality (TOQ) Strategic Sourcing has responsibility for managing and... ....This position is hybrid and will be primarily located... ...leaders across R&D, CMC, and Quality to influence... ...other peers within the Global Strategic Sourcing...SuggestedFull timeContract workTemporary workLocal areaFlexible hours$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....Suggested$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- ...in Boston, MA seeks an Executive Director of Portfolio & Program Management to lead global PM efforts across the drug... ...commercialization. Based in Boston with a hybrid schedule (3 days in office, 2... ...senior directors and drive strategic growth and operational excellence...SuggestedWork at officeRemote work
- 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...SuggestedWork at officeRelocation
- ...Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2... ...interactions (FDA, EU, MHRA), and provide strategic guidance while partnering with Clinical Development, CMC, and Quality to advance innovative...Work at office3 days per week
$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- ...sustainable and more connected world. Why you should join:The Manager, Global Demand Planning is the global process owner and capability... ...of global planning processes • Experience operating in matrix / hybrid BU-regional modelsSkills & Competencies:• Strong analytical and...Local area
$212.03k - $318.05k
...ambition and operational execution. About the role As our Senior Director, Global Demand Planning, you'll own the LEGO demand planning... ...communicated upon finalisation of the employment offer.#LI-Hybrid#LI-MD1 #LI-SW2Applications are reviewed on an ongoing basis. However...Full timeWork at officeImmediate startRelocation3 days per week- ...challenge the status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases... ...doReporting to the Lead, HIDO Global Strategic Insights, the Senior Manager, HIDO Global... ...Rare Disease experienceLocationThis is a hybrid position that is based in Boston, MA and...Hourly payLocal areaRemote workRelocation packageFlexible hours
$108.6k - $195.4k
...being a trusted business partner? Join our global tax team Our global tax team based in... ...and Accounting. You will report to the Director of International Tax, and this role will... ...provisions. Monitoring and analyzing tax regulatory and compliance developments, accounting...Remote jobWork experience placementWork at officeWorldwide$177k - $278.08k
...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you... ...clinical, safety, medical affairs, and commercial, to ensure... ...and/or related experience.Strategic ThinkingAbility to develop... ...accordance with Takeda's Hybrid and Remote Work policy.#LI-...Minimum wageLocal areaRemote workWorldwide$196.7k - $353.4k
...Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology... .... The Sr. Director will be a strategic leader within Regulatory Affairs, responsible for developing and... ...articulate clear and compelling global regulatory strategies, highlighting...Permanent employmentFull timeWork at officeWork from home- ...Therapeutics is seeking an Associate Director of Business Operations for Global Quality Control to lead governance, portfolio management, and strategic planning that enable disciplined execution... ...including compliance and cost efficiencies, in a hybrid #J-18808-Ljbffr Moderna
$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...Work at office$190.5k - $270k
## Director, Global Patient Strategy & Market Development,... ...Analytics, GPPS, Corporate Affairs, the global and US... ...adapted to different regulatory and cultural... ...engagement.• Support strategic engagement with patient... ...Cambridge, MA HQ on a hybrid model including working...Temporary workLocal areaFlexible hours$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 wageWork at officeLocal areaRemote workNight shift- Sr. Manager, Global Planning Job Description Summary: Key contributor to clinical supply... ...supports others in the group to provide strategic planning and execution recommendations. Collaborate... ...plans from program management and CMC. Partners with CMC, Process Sciences,...Temporary workShift work
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...
- AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch... ...authorities and collaborate with global teams to shape regulatory strategies... .... With 6+ years in regulatory affairs, you will oversee risk assessments,...Local area
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing... ...skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AG
- AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and... ...compliance. The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and staying ahead of evolving laws....Local area
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities. The...
- Celldex Therapeutics, Inc. is seeking a Senior Director, Regulatory Science and CMC Development Strategy to lead early-stage CMC regulatory strategy... ...portfolio. This senior leader reports to the VP, Regulatory Affairs and partners with Manufacturing and Quality to align...
- ...Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience... ...(GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May...Worldwide
- AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for Neuroscience. You will develop global regulatory strategies, lead the GRPT, oversee dossier development, and ensure compliant submissions across US, EU, and other regions....
$137k - $215.27k
...Lead the development and advancement of Global Patient Access strategies across programs... ...align with enterprise priorities, regulatory requirements, and product lifecycle needs... ...Access Strategy & Operations. This is a hybrid role based in Cambridge, MA. How you will...Minimum wageFull timeContract workLocal areaRemote workNight shift$212k - $333.19k
...Description Join Takeda as the Global Market Access Strategy,... ..., integrated evidence plans, regulatory pathways and launch plans.... ...Operating Company teams. Provide strategic input to disease-area... ...and domestically as required; hybrid classification subject to applicable...Minimum wageFull timeWork at officeLocal areaRemote work- A global biopharmaceutical company is seeking a Director, Value & Access, Marketing & Strategy to lead marketing initiatives in the Oncology business unit. The... ...skills, and a BA/BS degree, with an MBA preferred. A hybrid work arrangement is available, based in Cambridge,...
$151.2k - $226.8k
...in Quincy, MA to lead complex programs and ensure alignment to strategic business outcomes. This role requires 10+ years of project management... ..., and financial reporting. The position offers a flexible/hybrid schedule with three in-person days per week and a competitive...Flexible hours3 days per week
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