Global Labeling Strategy Lead - Associate Director - Hybrid
Takeda Pharmaceuticals
Takeda's Plasma-Derived Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical, Pharmacovigilance, Legal, and Commercial teams to shape labeling for pharmaceutical drugs and devices and ensure alignment with Health Authority expectations. This leadership role oversees CCDS, USPI, and EU SmPC labeling activities, mentors cross-functional teams, and #J-18808-Ljbffr Takeda
$154.4k - $242.55k
...Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU)... ...and compliance activities.Location: Cambridge, MA (Hybrid)Takeda Compensation and Benefits SummaryWe understand...SuggestedMinimum wageTemporary workLocal area- ...Cambridge, MA, is seeking an accomplished Associate Director of International Tax to drive global tax planning and compliance. In this hybrid role, you'll serve as a key advisor to... ...leadership and ensure alignment of tax strategies with business objectives. The ideal...SuggestedFlexible hours
$154.4k - $242.55k
...knowledge.Job DescriptionLead, Global Pricing, Oncology (Associate Director)Takeda... ...MAAbout the role:This role will lead the development of global pricing strategies and drive operational implementation... ...is currently classified as "hybrid" in accordance with Takeda's...SuggestedMinimum wageTemporary workLocal areaRemote work$169.4k - $266.2k
...deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Director, Global Scientific Communications Group Lead. This is a hybrid role based in Cambridge, MA.As a... ...of scientific communications strategy and deliverables, you will proactively...SuggestedMinimum wageTemporary workFor contractorsFreelanceLocal areaRemote work$153.6k - $241.34k
...best of my knowledge. The Associate Director/Lead, US Solid Tumor Forecasting... ...franchise, as part of the larger Global Insights and Analytics... ...leads by driving forecast strategy and providing data-driven insights... ...currently classified as "hybrid" in accordance with Takeda'...SuggestedMinimum wageFull timeTemporary workLocal areaRemote work- ...Therapeutics in the United States is seeking an Associate Director, Labeling and Disclosures to lead global labeling for development and marketed products and... ...regulatory integrity, and drive compliant labeling strategies worldwide while coordinating with vendors and...Worldwide
$163.2k - $244.8k
...DescriptionGeneral Summary:The Associate Director, Global Submission Management... ...global regulatory strategies and operational... ...Major Submission Leads, Global Regulatory Strategy... ..., Regulatory CMC, Labeling, Publishing, and Advertising... ....Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...Purpose: Defines, develops and leads global strategies to maximize global... ...counterparts.Accountabilities:The Associate Director will be responsible for... ...groups, such as the Label Working Group, and represents... ...currently classified as “hybrid” in accordance with Takeda...Minimum wageTemporary workLocal areaRemote work- Beeline Medicines in Boston is seeking a Director of Regulatory Strategy to lead the global regulatory strategies for early-stage and pipeline programs in the... ...engagements. A comprehensive benefits package and hybrid work arrangements are offered. #J-18808-Ljbffr Beeline...
$168k - $252k
...Summary:The Regulatory Strategy Associate Director will be responsible... ...development of regional or global regulatory strategy... ...a global regulatory lead, or in some cases a... ...the market, product labeling, reporting, and surveillanceAbility... ....Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week$160.8k - $201k
...our website: The Importance of the Role The Associate Director, Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed... ...to the formulation of global labeling strategy and assists international regulatory...Full timeWork at officeLocal areaImmediate startWorldwide- ...continuously challenge the status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a... ...will doReporting to the Head of Access Marketing, Strategy, & US HEOR for the Americas, this role will lead the development and implementation of Access...Hourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology... ...RNA technology in the US and other global markets. Responsibilities Serve as the global regulatory lead delegate for development compounds in...
- A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience... ..., to ensure alignment between US and global strategies. Exceptional communication skills...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for... ...program oversight. Work Arrangement & Location Hybrid - This position follows a hybrid work schedule, requiring...Local areaFlexible hours2 days per week$328k
...Summary:The Executive Director, Global Medical Lead (GML), HEME is a... ...the global medical strategy and implementation and... ...funds allocation, and associated tracking to ensure... ...Medical Affairs in label discussionsSupport Access... ....Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week$169.4k - $266.2k
...The GMAO External Engagement Lead will be responsible for collaboratively... ...scientific engagement strategies across the oncology portfolio.... ...role supports Takeda Oncology’s global medical affairs objectives by... ...digital scientific exchange, hybrid engagement models, data‑driven...Minimum wageTemporary workLocal area$185.37k - $308.95k
Associate Director, Medical Review Lead, MSRM Who we are At Agios, we are fueled by connections... ...partners closely with Global Safety Leads,... ...either remote in the US or hybrid in our Cambridge Headquarters... ...connected to our business strategy and vary based on individual...Temporary workRemote workWork from homeFlexible hours3 days per week$178.1k - $244.86k
...displayed reflects the primary location associated with this posting. Compensation may... ...development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment... ...access globallyACCOUNTABILITIES Lead end-to-end strategy development and...Minimum wageTemporary workLocal areaNight shift- ...compliant, cost-effective delivery of investigational products to global sites and partner with Clinical Operations, Quality, Regulatory... ...supply chain, with deep experience in global clinical trial supply, labeling, packaging, IRT/IXRS, and #J-18808-Ljbffr Korrobio
$154.4k - $242.55k
...DescriptionAbout the Role:As the Associate Director of HCP Branded Strategy and Marketing, you will... ...culture and values while leading the HCP branded strategy... ...work.Certified as a Global Top Employer, Takeda offers... ...currently classified as "hybrid" in accordance with...Minimum wageTemporary workFixed term contractTerm timeLocal areaRemote work$154.4k - $242.55k
...worldwide.This role is within the Global Regulatory Affairs (GRA)... ...minimal supervision, develops and leads the execution of regulatory... ...and/or post-approval strategies for assigned products. RA CMC... ...is currently classified as "hybrid" following Takeda's Hybrid and...Minimum wageTemporary workLocal areaRemote workWorldwide$120k - $135k
...are impact-obsessed. As a global agency, we provide a full... ...Chemistry is looking for an Associate Director, Medical Strategy tojoin our growing team!... ...strategic thinking.This is a hybrid role, based in any of our... ...leadership: Lead, shape and execute strategy...Work at officeLocal areaRemote work2 days per week- ...Cambridge, Massachusetts, seeks an MSL Team Lead responsible for overseeing the regional MSL team. This role focuses on developing strategies and fostering relationships with key... ...discourse while leading an effective team. This hybrid position requires occasional office...Work at office
- Sanofi Inc. is seeking a Global Brand Lead for Transplant (Solid Organ Transplant) based in the U.S. This senior role leads the end-to-end SOT strategy, P&L, and market execution, collaborating with Medical Affairs, Market Access, Digital, Regulatory and regional teams...
- Isomorphic Labs in Cambridge, MA seeks a Senior Head of Global Regulatory Affairs and Strategy to build the regulatory function from IND/CTA through NDA/BLA/MAA. You’ll design systems for GxP, PV, and Medical Writing, leveraging AI to speed regulatory decisions and approvals...
- Sarepta Therapeutics seeks an Associate Director, Labeling and Disclosures to lead global labeling activities for development and marketed products. You will coordinate CCDS, TPL, and local labeling with cross-functional teams and Health Authorities to ensure regulatory...Work at officeLocal area
- Moderna Therapeutics seeks a Global Competitive Intelligence Lead - Oncology to design and execute the oncology CI strategy across all programs globally. You will guide product positioning, scenario planning, and GTM strategies, shaping launches and lifecycle management...
- Sanofi is seeking a Global Lead for Medical Intelligence to Strategy in Cambridge, MA (with travel to Morristown, NJ). The role advances predictive intelligence across Medical Affairs by integrating clinical evidence, real‑world data, and digital health data streams. You...
- Global Lead, Medical Intelligence to Strategy Location: Cambridge, MA, Morristown, NJ At Sanofi, we chase the miracles of science to improve people's lives. We are accelerating Sanofi's modernization journey, supporting our Take the Lead strategy to become more focused...Shift work
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