Global Regulatory Strategy Lead Drive Lifecycle
Selby Jennings
EPM Scientific is seeking an experienced Global Regulatory Affairs Lead to drive worldwide regulatory strategy for a late-stage/marketed biologic across multiple indications. You will lead global regulatory planning, health authority engagement, lifecycle management activities, and a cross-functional regulatory team supporting both approved and development-stage programs. The role requires senior leadership communication, successful cross-functional collaboration, and a strong track record in #J-18808-Ljbffr
- ...Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions with... ...international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements...Regulatory
- ...Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program,... ...and managing health authority interactions to drive #J-18808-Ljbffr ClinLab Solutions GroupRegulatory
- ...LLC is seeking a strategic leader to head Global Regulatory Affairs for the Therapeutic Dermatology portfolio. You will drive regulatory strategy, manage interactions with the FDA and EU authorities, and coordinate lifecycle activities across R&D, Operations, and Regions...Regulatory
- ...Takeda seeks a Global Medical Lead, Nephrology for the Cambridge, MA area to drive end-to-end medical strategy and cross-functional execution across Clinical, Regulatory and Commercial partners. You will lead medical narrative development, advisory boards, and launch...Regulatory
- ...Director of Biostatistics to lead statistics for BioCryst-... ...ensure GCP conformance, and drive outsourcing strategy aligned with Biostatistics... ...demands deep study design, regulatory strategy, programming expertise... ...and mentor a team across global sites. #J-18808-LjbffrRegulatory
- ...in Boston seeks a Senior Global Medical Affairs Leader (... ...MASH to shape medical strategies across weight management... ...cross-functional teams, drive evidence generation, and align with regulatory, payer, and clinical stakeholders... ...Management, you will lead global medical agendas,...RegulatoryWorldwide
- ...Relay Therapeutics seeks a Regulatory Project Manager to orchestrate global filings and cross-functional plans for a growing... .... You will partner with Regulatory Leads to translate strategies into actionable submission timelines and drive adherence to deadlines. You will...Regulatory
- ...Pharma in Cambridge, MA, seeks a Global Asset Lead to own the strategic vision... ...program across development, regulatory, and commercial functions.... ...and Commercial efforts, and drive evidence generation for... ...Phase 1/2 through launch and lifecycle management. #J-18808-LjbffrRegulatory
- ...Sanofi in the US seeks a Global Periodic Reporting Lead based in Cambridge, MA (also Morristown, NJ and Swiftwater, PA). You... ...portfolio. You will develop outsourcing strategies, ensure regulatory compliance, and drive Lean process improvements to boost efficiency...RegulatoryWorldwide
$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard... ...the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability...RegulatoryWork at officeFlexible hours2 days per week- ...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...Regulatory
- ...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... ...teams and oversee all FDA submissions, driving strategic regulatory initiatives aligned with...Regulatory
- ...Boston, MA is seeking a Senior Global Environmental Compliance Specialist to lead our environmental product compliance strategy across global markets. You will own the framework, drive regulatory reporting, and ensure product lifecycle compliance from concept through...Regulatory
- ...Alpha-9 Oncology seeks an experienced Associate Director, Regulatory Affairs to lead global regulatory strategy and submission planning across our clinical pipeline. Reporting to the Vice President, Regulatory Affairs, this hands‑on role helps shape strategy and execute...Regulatory
- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic... ...role partners with the Global Regulatory Lead to ensure robust global project plans, cross... ...align operational plans with GTMs, and drive strategic execution with vendors and external...RegulatoryRemote work
- ...innovation? As the Senior Global Medical Affairs... ...entire product lifecycle. You'll advise on... ...decisions, lead pre-launch scientific... ...collaboration and drive innovation. Are you... ...leads bold medical strategies for MASH within the... ...system pathways, regulatory landscapes, market...RegulatoryFull timeWorldwideRelocation package
$202.4k - $265.7k
...are looking for a RWE Strategy Lead Developed Brands, Immunology... ...and execution of global real-world evidence (... ...for existing product lifecycle and translate them into... ...strategies that inform regulatory, market access,... ...external landscape. You will drive the use of innovative...RegulatoryPermanent employmentContract workWork at officeLocal area- ...Olema Oncology seeks a Director, Global Regulatory Strategy Lead to guide innovative regulatory strategies across its oncology portfolio... ...), and partner with global health authorities to drive product development and lifecycle plans. You will mentor a growing Regulatory...Regulatory
- ...DSJ Global seeks an Associate Director, Product... ...senior leadership role drives planning, readiness,... ...launches and major lifecycle initiatives across... ...manufacturing, quality, and regulatory teams. You will develop launch strategies, identify risks early, and lead cross-functional...Regulatory
$210.9k - $379.2k
...worldwide, contributing to global health initiatives.... ...a Global Medical Lead to lead medical affairs strategy across our Oncology... ...leadership, and driving scientific thought... ...extensively with regulatory, clinical, commercial... ...development to lifecycle management.Serving...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide- ...in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure... ...labeling, manage SPL submissions, and drive lifecycle labeling from development through post-marketing...RegulatoryWork at officeRelocation
$206.25k - $297.92k
...: Real World Evidence Strategy LeadLocation: Morristown... ...(RWE) Strategy Lead, you will establish and... ...RWE strategies across global Therapeutic Areas, translating... ...into evidence that drives regulatory, access and medical... ...indications and other lifecycle strategies in development...RegulatoryFull timeLocal area$232.5k - $320k
## Global Brand Lead, NavtemadlinPostuler: Cambridge (US): Temps complet... ...shaping and delivering the brand strategy for Navtemadlin, a Phase 3... ...Medical, Market Access, Regulatory, Insights, Finance, Supply,... ...US market requirements.* Drive lifecycle management strategies that...RegulatoryTemporary workLocal areaFlexible hours$155k - $213.5k
...myGwork – the largest global platform for the LGBTQ+... ...This Role The US Lifecycle Management Lead is a senior individual... ...robust supply, quality, regulatory, and flow‑of‑goods strategies. You will partner closely... ...identifies risk early, drives mitigation strategies,...RegulatoryTemporary workLocal area- Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings...Regulatory
- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...RegulatoryWork at office3 days per week
- ...About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services... ...cutting-edge projects that drive meaningful impact across pharmaceuticals... ...successful development and lifecycle management of global... ...will lead labeling strategy across development and marketed...RegulatoryPermanent employmentRemote work
$154.4k - $242.55k
...Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived... ...the PDT BU via the development and lifecycle management of the CCDS, US, and EU... ...external multiple stakeholders to drive solutions and set prioritiesHigh ability...RegulatoryMinimum wageLocal area$200k - $265k
...bold ambition to become the leading dermatology company in the... ...impact.The OpportunityLeads the global regulatory strategy, submission planning, and... ...nemolizumab and for driving successful regulatory outcomes across the product lifecycle.Key Responsibilities Accountable...RegulatoryFull timeTemporary workWork experience placementWork at officeWorldwide- ...Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the USA. The role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs...RegulatoryRemote work
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