Global Regulatory Labeling Strategy Director
Vertex Pharmaceuticals Inc (US)
Vertex Pharmaceuticals Inc. is seeking a Regulatory Labeling Director to lead strategic development of global labeling for marketed products, including CCDS and regional labeling (PI, PIL, IFU) across US, EU, GB, and CA. The role interfaces with FDA, EMA, and Health Canada, and guides governance and negotiation with regulators. The position demands a strong track record in regulatory labeling, cross-functional leadership, and the ability to translate complex requirements into actionable #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)
- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling content and strategy for multiple products in various stages of drug development. The role requires 10+ years of pharmaceutical...Regulatory
$177k - $278.08k
...boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple...RegulatoryFull timeTemporary workLocal areaWorldwide- ...AstraZeneca is seeking a Senior Regulatory Affairs Director in Boston, MA to lead global regulatory strategy for oncology programs. The role involves overseeing a Global... ...Regulatory Strategy Team and ensuring competitive labeling. The ideal candidate has an advanced degree in...RegulatoryWork at officeRemote work
- Vertex Pharmaceuticals seeks a Director of Regulatory Labeling Strategy, remote-eligible, to lead the strategic development of global labeling for one or more marketed products. You will oversee CCDS, PI, PIL, IFU, and other labeling deliverables across major markets....RegulatoryRemote job
$209.35k - $258.6k
Akebia Therapeutics(R), Inc. in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This leadership role will shape global labeling strategies for the product portfolio. Candidates should have over 10 years in regulatory labeling within pharmaceuticals...Regulatory- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies... ...of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as...RegulatoryWorldwide
$245k - $300k
Merida Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics...Regulatory- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...Regulatory
$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience in the pharmaceutical industry, with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have...Regulatory- JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This role involves developing innovative global regulatory strategies and leading Global Regulatory Teams. The ideal candidate will have 10+ years of experience in the pharmaceutical...Regulatory
- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic... ..., ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of...Regulatory
- 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...Regulatory
- 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...Regulatory
$185.6k - $278.4k
General Summary The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible... ...selected markets (US, EU, GB, CA). Leads labeling strategy with expert ability to advise stakeholders of...RegulatoryRemote jobFull timeLocal area2 days per week- Vertex Pharmaceuticals Inc (US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their portfolio. The role involves leading regulatory submissions and mentoring team members on regulatory frameworks...Regulatory
$183.55k - $275.32k
Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At Agios, we are fueled by connections to transform... ...This individual will be responsible for development of global labeling documents (e.g. CCDS, regional product...RegulatoryTemporary workLocal areaRemote workWork from homeFlexible hours3 days per week- Agios Pharmaceuticals seeks a Director/Sr. Director for Regulatory Labeling Strategy to provide strategic regulatory guidance. You will oversee labeling activities and ensure compliance with FDA regulations. This role involves collaboration with Legal, Commercial, and...RegulatoryRemote work
$136.9k - $185.2k
...Overview: The Senior Manager, Global Planning is a key member of the Global Supply... ...ensure compliance with respective countries regulatory approval timelines. Serve as a key... ...to develop scenario plans and strategies that translate into production plans meeting...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AGRegulatory
$211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...RegulatoryHourly payTemporary workWork at office3 days per week- ...and integrated evidence plans to support global market access and value Develop of the global pricing and market access strategy, payment models and negotiation approach quality... ...(e.g. commercial, product development, regulatory affairs). Collaborate closely with HEOR,...RegulatoryRemote workFlexible hours
- Akebia Therapeutics is looking for a Director of Global Logistics in Cambridge, MA. The successful... ...development and execution of logistics strategies to support global supply chains, manage vendor relationships, and ensure regulatory compliance. The role requires a...Regulatory
- AstraZeneca GmbH is seeking a Regulatory Affairs Director to provide strategic regulatory leadership within their Cardiovascular, Renal & Metabolism team. You will define and implement regulatory strategies for innovative medicines, engage with health authorities, and...Regulatory
$196.7k - $353.4k
...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development...RegulatoryPermanent employmentWork at officeWork from home- ...MA is seeking a senior commercial leader to shape and drive global strategies across Weight Management assets. You will lead cross-functional... ..., and delivering strong asset value while partnering with Medical, Regulatory, and R&D teams. #J-18808-Ljbffr AstraZeneca GmbHRegulatory
- Regulatory Strategy Senior Director page is loaded## Regulatory Strategy Senior Directorlocations: Boston, MAtime... ...strategy for the assigned global or regional position and will be responsible... ...data, protocols, safety reporting, labeling and other activities related to the...RegulatorySummer workLocal areaRemote workFlexible hours2 days per week3 days per week
$320k
A global pharmaceutical company is seeking a Head of Regulatory Legal to lead and develop the legal strategy for Global Quality, R&D, and Regulatory Affairs. The position involves providing legal counsel on regulations and compliance, guiding senior leadership, and managing...Regulatory- A global biopharmaceutical company based in Boston seeks a Director, Safety Scientist to lead risk management and mentor junior scientists. Responsibilities include managing safety evaluations, preparing regulatory documents, and representing global safety at inspections...Regulatory
$320k
Job Overview The VP Head of Global Product Strategy for Neuroscience is a strategic leadership position accountable for the development and... .... Strong understanding of drug development processes and regulatory pathways, product supply issues, and new product evaluation...RegulatoryMinimum wageTemporary workLocal area- Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and... ...programs, aligning with regulatory strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion...Regulatory
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