Senior Regulatory Affairs Lead — Global Strategy & Lifecycle
$193k - $210kKatalyst CRO
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle. Candidates should hold a PhD in health or life sciences, with 6+ years of relevant experience. Responsibilities include ensuring alignment with clinical plans and incorporating global Health Authority feedback. This role offers a competitive salary between $193,000 and $210,000. #J-18808-Ljbffr Katalyst CRO
- Vertex Pharmaceuticals is seeking a Regulatory Strategy Senior Director to lead regulatory approaches for various projects. The role, located in Boston,... ...candidate will possess significant expertise in regulatory affairs, strategic thinking, and excellent communication...Senior3 days per week
$151k - $297k
MongoDB is seeking a Senior Director for HR to partner with leadership and drive complex global change. This role involves shaping people strategy, driving revenue growth, and building leadership capability. Ideal candidates will have over 12 years in HR, including experience...SeniorFlexible hours$240k - $360k
Key Responsibilities Evolve global pricing & market access (P&MA) strategy for povetacicept across cross-functional,... ...communications and supportive training. Lead evolution of global price and... ...HEOR, Real World Evidence, Government Affairs, and Public Policy to deliver...Senior$240k - $360k
...autoimmune disease of the kidney that can lead to end-stage-renal disease. IgAN... ...(gMG). Vertex is seeking a Senior Director of Global Value & Access Strategy (GVAS) for povetacicept, reporting... ..., Real World Evidence, Government Affairs and Public Policy and to ensure alignment...SeniorSummer workRemote workWorldwideFlexible hours2 days per week- A global pharmaceutical company seeks a Regulatory Affairs Specialist in Boston, MA. The role involves developing regulatory strategies for prescription drug submissions and managing lifecycle activities. Candidates should have a Bachelor's with 5+ years in regulatory...Suggested
$89.6k - $157k
Wolters Kluwer is looking for a seasoned Event Manager to lead strategy and execution of high-impact internal and external events in Boston. This role entails managing the full event lifecycle from budgeting to logistics while ensuring operational excellence within a fast...Senior- Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview Senior... ...development and post-approval lifecycle Supports regulatory submissions... ...Strategy & Submissions Lead execution of global CMC regulatory...Senior
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior... ...programs Implement compliance strategies and processes Prepare, review, and... ...skills and knowledge in regulatory affairs Strong strategic planner with a proven...SeniorFull timeLocal area
$212k - $333.19k
...patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...and ideas into actionable strategies. You will set global regulatory direction... ...understanding broad concepts within regulatory affairs and implications across the...SeniorMinimum wageTemporary workLocal areaWorldwide$212k - $333.19k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program... .... Accountabilities: The Senior Director will be responsible for... ...broad concepts within regulatory affairs and implications across the organization...SeniorMinimum wageTemporary workLocal area- ...Pharmaceuticals in Boston is seeking a Regulatory Strategy Associate Director responsible for overseeing global and regional regulatory... ...understanding of regulatory affairs, drug development, and experience... ...potential bonuses, and market-leading benefits. #J-18808-Ljbffr...
- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...
- Job Description OBJECTIVES/PURPOSE Lead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle needs Drive data‑driven and technology‑enabled...Full timeLocal areaNight shift
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Senior
- EY-Parthenon seeks a Senior Director to lead in its Strategy and Execution Supply Chain practice. You will guide complex transformation programs across the transaction lifecycle, advising global clients on integrations, divestitures, and supply chain improvements. The role...Senior
- Senior Director, Program Leader, Corporate Strategy At Agios, we are fueled by connections... ...through regulatory approval, launch, and lifecycle management,... ...fully integrated global asset strategy... ...mitigation strategies. Lead asset... ...with Regulatory Affairs to guide global...Senior3 days per week
$214.9k - $358.1k
...depend on us. In Global Commercial Strategy (GCS), we... ...growth, and LOE lifecycle. GCS serves as the... ...evidence generation, leading global launches,... ...Achieve The Senior Director, IM Portfolio... ...R&D, Medical Affairs, GASP, BAI, Competitive... ...statutory or regulatory clarification,...SeniorPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation packageShift work- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience in regulatory affairs and a strong background in drug development. The ideal candidate will have over 12 years in the pharmaceutical...Senior
- Lendbuzz Inc. is seeking a Senior Manager, IT Systems to lead their IT department. The ideal candidate will develop IT strategies and manage a team to ensure successful execution of initiatives, driving business growth. Responsibilities include overseeing IT operations...Senior
$137k - $215.27k
JobRx, Inc. is seeking a Manager Regulatory Lead based in Boston, MA to oversee and implement regulatory strategies for plasma-derived therapies. This role involves coordinating the Global Regulatory Team, ensuring compliance with FDA requirements, and managing submissions...Senior- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRemote job
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Senior- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory...Senior
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the... ...As a key member of the Regulatory Affairs team, this individual also contributes... ...informed and involving senior management at key decision points....Local areaFlexible hours2 days per week- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...
- Vertex Pharmaceuticals Incorporated is seeking a Senior Director, HRBP to provide strategic HR partnership to leaders across Global Commercial Strategy, U.S. Pricing & Access / Government Affairs, Global Pricing, and HEOR. Reporting to the Head of HR for Commercialization...Senior
$218.4k - $327.6k
Job Description The Senior Director, BSMO (... ...Disease) Disease Area Lead represents BSMO at the GKD Disease Strategy Team (DST). The... ..., Supply Chain, Regulatory, Finance, and other... ...development, launch, and lifecycle management of... ...Vertex is a global biotechnology company...SeniorSummer workRemote workFlexible hours2 days per week- Mass Digital Health is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies across its product portfolio. Based in either Morristown, NJ, or Cambridge, MA, this role is vital to ensure compliance with industry standards while advocating...
- ...Therapeutics seeks a Global Competitive Intelligence Lead - Oncology to... ...execute the oncology CI strategy across all programs... ...launches and lifecycle management. The role... ...collaborating with Medical Affairs, Market Access, and... ...insights to senior leadership. #J-188...
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