Global Labeling Strategy Director Lead US Labeling
Alnylam
Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function within the Global Labeling team. The role shapes CCDS, CPI, and TLPs, guiding evidence plans and negotiation pathways for multiple regions.
You will influence study design, evidence elements, and health authority interactions across disciplines. Ideally, you bring 12+ years in biopharma regulatory affairs with strong labeling experience, strategic judgment, and
#J-18808-Ljbffr- Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution. This role...SuggestedRemote job
$154.4k - $242.55k
...Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is... ...development and lifecycle management of the CCDS, US, and EU labels.Formulates and implements innovative...SuggestedMinimum wageLocal areaRemote work- ...Vertex Pharmaceuticals is seeking a Packaging and Labeling Manager to lead end-to-end artwork development, review, and implementation across global markets. You will coordinate with Regulatory Labeling, QA, Supply Chain, MS&T, and external partners to ensure on-time delivery...SuggestedRemote work
$177k - $278.08k
...to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for... ...)In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling... ...Regulatory Team (GRT)Liaises with US Labeling Operations, EU Labeling...SuggestedMinimum wageLocal areaRemote workWorldwide- ...is seeking a senior regulatory leader to define and execute global labeling strategy across the product lifecycle. You will translate clinical evidence... ...with global regulators, including the FDA. You will lead and develop internal teams, manage consultants, and drive the...Suggested
- ...GlaxoSmithKline is seeking a Manager, Strategic Labelling & Development to lead the creation and maintenance of Global Datasheets for medicines, ensuring labeling content... ...GSK's medical position. The role supports US PI, EU SmPC, and patient information across markets...
- ...Kailera Therapeutics is seeking an Associate Director, Global Regulatory Labeling and Ad Promo in Waltham, MA to lead labeling strategy and cross-functional regulatory activities. This role focuses on U.S. labeling development, FDA interactions, and ensuring regulatory...
- Akebia Therapeutics 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 complies with FDA and global requirements. You will influence senior...Work at officeRelocation
- Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products... ...role offers the opportunity to shape regulatory strategy, manage IPD disclosures, and collaborate with...Local area
- ...AbbVie is seeking a Senior Manager Regulatory Affairs to lead Global Regulatory Strategy for US & Canada. You will shape regulatory plans for on-market and development products and ensure compliance with US/Canada requirements, coordinating with global teams. You will...
- ...AbbVie's Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada, is responsible for developing and implementing regulatory strategy for US and Canada, ensuring alignment with GRPT and regulatory requirements. The role interfaces with FDA and coordinates submissions...
$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global... ...Accountabilities: The Director will be responsible for complex... ...working groups, such as the Label Working Group, and represents... ...solutions. Accountable for all US FDA submissions and...Minimum wageFull timeLocal areaRemote work- ...State Street Corp seeks a Head of Active ETF Strategy in Boston to lead a global team focused on the Active ETF lineup (US-listed and UCITS). You will guide investment research, competitive positioning, and go-to-market strategy, serving as a subject matter expert for...
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global... ...programs Implement compliance strategies and processes Prepare,... ...working groups, such as the Label Working Group, and represents... .... Accountable for all US FDA submissions and approvals...Full timeLocal area
$196.7k - $353.4k
...Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology... ...clear and compelling global regulatory strategies... ...direction and leads the development of content... ...of the Target Label Profile and the Company... ...knowledge of current US and EU regulations, including...Permanent employmentWork at officeWork from home- ...translating the TPP as set by the Asset Strategy Team into a Clinical Development Plan that... ...in the indicationLine management of the Global Clinical Trial Physicians working on the... ...management of the different functional groups. Lead indication medical ad boards as...
- ...applicable law. Job Purpose The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a... ...management, and post-approval regulatory strategy for FDA and internationally approved veterinary...
- ...Job title: US Medical Director, Transplant CLAD ~ Location... ...of US medical strategy for transplant products... ...with the US Medical, Global Medical and brand strategy... ...management and execution; Lead innovative solutions... ...treatments, product labeling and Federal...
- .... in the U.S. (Sumitomo Pharma America, Inc.) seeks an accomplished Regulatory Leader to guide global and regional regulatory strategies for the CNS portfolio. You will lead the Global Regulatory Team, coordinate submissions, and collaborate with cross-functional teams...Remote work
$116k - $145k
...implementation of regulatory strategy for assigned markets &... ...& activities.This is a US based remote position.... ...regulatory affairs clinical lead for clinical trial... ...release, CTA Questionnaires, label review, etc.Reviews of... ...regulatory support to Global Regulatory Lead in definition...Full timeWork at officeRemote work- ...Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and... ...submission of regulatory documents to the US. Applicants should have a Bachelor's...
- ...seeking a Regulatory Affairs Director to provide strategic and... ...programs. The role spans global/regional leadership, drafting strategy, and engagement with... ...authorities. The RAD will lead cross-functional teams, shape... ...to drive rapid, well-labeled approvals. #J-18808-Ljbffr...
$171.6k - $286k
...myGwork - the largest global platform for the... ...Global Regulatory Strategy organisation,... ...Inflammation portfolio. As Director, Global Regulatory... ...Global Regulatory Lead or Regional... ...support appropriate labelling based on the... ...the United Kingdom, US, or Belgium and offers...Work at officeLocal areaRemote work- ...about AbbVie, please visit us at Follow @abbvie on X, Facebook... ...Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for... ...regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST...Temporary workWorldwide
$212k - $333.19k
...that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office.At Takeda, we... ...overarching Global Program(s). The GPL defines the asset strategy and leads all development and LCM projects associated...Minimum wageWork at officeLocal areaRemote work- Sr Global Feasibility Lead - Sponsor dedicated (UK, Poland, Spain or US) Syneos Health® is a leading fully-integrated life sciences... ...Business Development, Medical Directors, Business Analysts, and other... ...methods to support study strategies aimed at becoming the subject...Contract workWork at officeFlexible hours
- AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs to lead regulatory strategy for US & Canada, ensuring alignment with GRPT and business needs. You will gather data to support filings and enable commercialization while liaising with Health Authorities...
- ...Bahnhofstrasse, we're expanding globally, with a growing... ...North America. Join us and help make... ...directly, a US country lead sitting next to you, and... ...on targeting, account strategy, and how the two motions... ...RevOps. We go in with a labeled hypothesis based on our...Temporary workLive inWork at officeLocal areaWorldwide
$215k - $230k
...experienced and strategic Director of Regulatory Affairs to lead the development and execution of global regulatory strategies supporting the Company's innovative... ..., manufacturing changes, labeling updates, software... ...interview process, please let us know. Salary...For contractorsLocal area$232.5k - $320k
## Global Brand Lead, NavtemadlinPostuler: Cambridge (US): Temps complet: Offre publiée aujourd'hui: R-22388**Titre :**Global Brand Lead, Navtemadlin**Socié... ...leader responsible for shaping and delivering the brand strategy for Navtemadlin, a Phase 3 oncology therapeutic in...Temporary workLocal areaFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Labeling Strategy Director Lead US Labeling. Be the first to apply!
- director of gift planning Cambridge, MA
- operation strategy cost manager Cambridge, MA
- director strategic marketing Cambridge, MA
- strategic director Cambridge, MA
- strategic finance manager Cambridge, MA
- director strategic initiatives Cambridge, MA
- strategic planning manager Cambridge, MA
- strategy & operations manager Cambridge, MA
- associate strategy director Cambridge, MA
- senior strategic account manager Cambridge, MA



