Global Regulatory Strategy Lead — Marketed Products
SoTalent
SoTalent is seeking an Associate Director, Global Regulatory Affairs to influence global regulatory strategy for innovative therapies. This role is critical in shaping regulatory strategies and ensuring successful outcomes with cross-functional teams. The successful candidate will have significant experience in Regulatory Affairs, strong leadership skills, and proven interactions with the FDA. You'll benefit from a competitive compensation package, bonus potential, and excellent healthcare benefits. #J-18808-Ljbffr SoTalent
- ...research, develop, and market innovative drugs... ...better. Chiesi Global Rare Diseases Chiesi... ...on research and product development for lysosomal... ...Access Marketing, Strategy, & US HEOR for the... ..., this role will lead the development... ...(Legal/Medical/Regulatory) and experience with...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...is seeking an experienced downstream marketing professional for the Interventional Technologies... .... You will translate upstream product strategy and clinical evidence into compelling... ...new products and indications, ensure regulatory compliance, and partner with Product Management...Regulatory
- ...Americas in Boston is seeking a Sr. Product Manager to drive product strategy, underwriting execution, and... ...portfolio performance across the US Middle Market. You will work with underwriting,... ..., claims, risk engineering, legal, regulatory, and distribution partners to shape...Regulatory
- ...seeking a Real-World Evidence (RWE) Strategy Lead Developed Brands, Immunology... ...strategies across the product lifecycle in a hybrid role, with... ...and 5-10% travel. You will lead global RWE programs, defining evidence needs for regulatory, market access, reimbursement, and patient...Regulatory
- A leading biotechnology firm in Boston is seeking a Regulatory Strategy Manager to oversee global regulatory activities for investigational products. This role includes preparing regulatory submissions, guiding the team on responses, and supporting NDA submissions. Ideal...Regulatory
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...Advice meetings, with a strong track record of productive agency relationships and strategic translation of feedback...RegulatoryLocal areaFlexible hours2 days per week$177k - $278.08k
...knowledge.Job DescriptionAbout the Role:Lead global market access and pricing strategy for Mezagitamab (TAK-079), an... ...markets.As a member of the global product and commercial teams and relevant... ...Access influence across clinical, regulatory, and commercial decision-makingIntegrate...RegulatoryMinimum wageTemporary workLocal area- ...strategic leader to own early commercial strategy for assigned programs, build disease/market landscapes, and partner with Clinical Development, Medical, Regulatory, and Leadership to shape target product profiles. You will lead indication prioritization, build market models...Regulatory
$177k - $278.08k
...Join Takeda as a Director, Global Regulatory Lead Oncology where you will be... ...will set global regulatory strategy and lead major submissions... ...initiatives.May partner with global market access colleagues to lead... ...agency/HTA bodies on product specific value evidence topics...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$180k - $245k
...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 and registration.... ..., including INDs, CTAs, marketing applications, Annual Reports,...Regulatory$202.4k - $265.7k
...patientsWe are looking for a RWE Strategy Lead Developed Brands,... ...development and execution of global real-world evidence (RWE) strategies... ...needs for existing product lifecycle and translate them... ...data strategies that inform regulatory, market access, reimbursement, and...RegulatoryPermanent employmentContract workWork at officeLocal area- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Regulatory
- ...innovation? As the Senior Global Medical Affairs... ...across the entire product lifecycle. You'll... ...decisions, lead pre-launch scientific... ...leads bold medical strategies for MASH within... ...Commercial functions in markets and regions... ...system pathways, regulatory landscapes, market...RegulatoryFull timeWorldwideRelocation package
$154.4k - $242.55k
...DescriptionAbout the Role:The Global Brand Lead, ITP (Associate... ...planning and early market development, translating early asset strategy into clear commercial... ...with Medical, Legal, and Regulatory teams to ensure materials... ...complexity: multiple products with multiple...RegulatoryMinimum wageTemporary workLocal areaRemote work$192.4k - $302.39k
...shine? Join us as a Global Medical Lead, Nephrology in our Cambridge... ...our R&D-driven market leadership and being... ...GPT) and global brand strategy. This includes incorporating... ..., Commercial, Regulatory, PV, Health Economics... ...strategy for defined products, aligned with the overall...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work$192.4k - $302.39k
...shine? Join us as a Global Medical Lead, PDT Hematology (f/m/... ...through our R&D-driven market leadership and being... ...Benign Hematology GM strategy in close collaboration... ..., Quality, Safety, Regulatory, Manufacturing, and Legal... ...future and current products and development of...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$80k - $140k
...Street's Alternatives Product organization including... ...AI-enabled content and marketing professional to... ...commercialization of our global Alternatives business.... ...help bring our product strategy, capabilities, and differentiation... ..., operational, and regulatory concepts into clear,...RegulatoryFull timeTemporary workFlexible hours$144.06k - $205.8k
...DescriptionLead, Access Marketing IZERVAY About... ...Astellas is a global life sciences company... ...readiness. The Lead, Access Marketing... ...engagement strategies for practice administrators... ...legal, regulatory, privacy, and promotional... ...the most productive work environment...RegulatoryWork at officeRemote workWork from homeWorldwide$136.86k - $195.51k
...DescriptionLead, Upstream Marketing - IZERVAYAbout... ...Astellas is a global life sciences... ...Purpose & Scope The Lead, Upstream... ...professional marketing strategies focused on educating... ...Access, Legal, Regulatory, and Compliance... ...optimize the most productive work environment...RegulatoryWork at officeRemote workWork from homeWorldwide$237.2k - $372.79k
...shine? Join us as a Global Medical Lead, Dermatology in our Cambridge... ...our R&D-driven market leadership and being... ...driving the medical strategy and execution of dermatology... ..., market access, and regulatory strategies. This role... ...Ph3b/4 plans for the product, providing scientific...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWeekend work$99k - $176k
...opportunity?Join our growing Global Asset Management (GAM)... ...at RBC! We are seeking a Lead Product Manager who will be focused on alternative strategies including Emerging Market Debt and Multi-Asset Credit... ...the competitive landscape, regulatory environment, industry flow...RegulatoryFull timeFlexible hours$212k - $333.19k
...supporting disease area strategy and early asset... ...scientific, clinical, regulatory, and competitive... ...demonstrated ability to lead in a highly matrixed global environment. You... ...evaluation, differentiation, market attractiveness, and... ..., including target product profiles,...RegulatoryMinimum wageLocal areaRemote work$192.4k - $302.39k
...Join us as a Director, Global Medical Lead, Zasocitinib-... ...through our R&D-driven market leadership and being... ...of the global medical strategy for zasocitinib in PsA... ...functional stakeholders on product profile, data... ...local practice, access, regulatory, and stakeholder needs...RegulatoryMinimum wageWork at officeLocal areaRemote work$212k - $333.19k
...as a Senior Director, Global Program Lead- Neuroscience in our... ...through our R&D-driven market leadership and being... ...defines the asset strategy and leads all development... ...driving regulatory approval as well as launch... ...required to bring the product to market and to ensure...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work$192.4k - $302.39k
....Job DescriptionThe Global Medical Affairs Lead, PDT Immunology is responsible... ...year global medical strategy for the PDT... ...Affairs, clinical, regulatory, safety, compliance,... ...differentiate SCIG products and support individualized... ...companies, Market Access, Global Outcomes...RegulatoryMinimum wageLocal areaRemote work- Moderna is seeking a Global Regulatory CMC Lead to coordinate CMC activities across product lifecycles and develop global regulatory strategies. You will guide product teams and manage multiple projects in a fast-paced environment to enable the next generation of medicines...Regulatory
- Alpha-9 Oncology is seeking an experienced Associate Director, Regulatory Affairs to join our Regulatory Affairs team and shape global regulatory strategy for our clinical pipeline. This hands-on leader will drive submission planning and interactions with health authorities...Regulatory
- ...Therapeutics seeks a Vice President, Marketing & Global Brand to own the global brand strategy and marketing organization as... ...therapy with a novel mechanism, leading a lean internal team, and... ...Market Access, Medical Affairs, and Regulatory to ensure readiness and market impact...Regulatory
- 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 immune and inflammation (I&I) therapeutic area. The role requires at least 10 years of regulatory experience,...Regulatory
- Scorpion Therapeutics seeks a Global Regulatory Lead to own global regulatory strategies from entry to lifecycle, providing strategic and technical leadership to a cross-functional team and serving as the primary regulatory voice with the US FDA. The role includes overseeing...RegulatoryLocal areaRelocation package
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