Global Labeling Strategy Director — Lead US Labeling
Alnylam Pharmaceuticals
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 Alnylam Pharmaceuticals
$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 area$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- Discover International is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide strategic labeling and ensure regulatory compliance for plasma-derived therapies. You will influence internal stakeholders across Clinical, Pharmacovigilance, Legal...Suggested
$185.6k - $278.4k
...DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products... ...For Use [IFU]) for select markets (e.g., US, EU, GB, CA).Lead labeling strategy with expert ability to advise...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week$142k - $190k
...This Role As an External Site Lead, within our Global External Manufacturing Team,... ...lead the process control strategy and execution at external manufacturing... ...oversight for assembly, label and pack. - Manage global... ..., and perspectives make us a stronger and more innovative...SuggestedContract workTemporary workLocal 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 employmentFull timeWork at officeWork from home$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global... ...counterparts. Accountabilities: The Director will be responsible for... ...working groups, such as the Label Working Group, and represents... ...solutions. Accountable for all US FDA submissions and approvals...Minimum wageFull timeLocal areaRemote workWorldwide- ...ApplicationsEmail: ****@*****.*** Medical Indication Lead (Rheumatology)The Global Medical Indication Lead will lead the clinical team for an indication, translating the TPP as set by the Asset Strategy Team into a Clinical Development Plan that answers the...
$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- ...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...Work from home
$328k
...DescriptionGeneral Summary:The Executive Medical Director, Global Medical Lead (GML), Pain is a critical leadership... ..., responsible for the global medical strategy and implementation and tracking of... ...product Represent Medical Affairs in label discussions Support Access, Patient...Full timeSummer workRemote workFlexible hours2 days per week- Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, optimize labeling, and shorten time to approval. You will manage global projects, interact with FDA/EMA, and coordinate...Remote jobWorldwide
- ...currently seeking to recruit an experienced Global Asset Lead (GAL) to take end‐to‐end accountability... ...) and business acumen (BD, portfolio strategy, and market dynamics).**Key... ...achieve a competitive and differentiated label that meets both regulatory requirements...Shift work
- 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...Work at office3 days per week
$122.25k - $176.58k
Job title: GRA Global AdPromo Excellence LeadLocation: Morristown, NJ - Cambridge, MAAbout the jobA hybrid role combining support for global... ...of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions...Full timeWork at officeLocal areaWorldwide$200k - $275k
About This Role: As the Director, Global Launch Excellence Lead for the SMA (Spinal Muscular Atrophy) portfolio,... ...Define and execute a global engagement strategy across healthcare providers,... ...backgrounds, cultures, and perspectives make us a stronger and more innovative...Full timeTemporary workLocal area$206.25k - $297.92k
Job title: Global Lead, Scientific Platforms & Engagement StrategyLocation: Cambridge, MA, Morristown... ...journey, supporting our Take the Lead strategy to become more focused, integrated, agile... ...- and innovative pipeline - enables us to invent medicines and vaccines that treat...Full time- ...medical innovation? As the Senior Global Medical Affairs Leader for... ...impact on patients' lives. Join us in our mission to transform... ...Development investment decisions, lead pre-launch scientific efforts,... ...and leads bold medical strategies for MASH within the Weight Management...Full timeWorldwideRelocation package
$154.4k - $242.55k
...The Brand Insights and Analytics Lead, US Oncology is an Associate Director-level role reporting to the Director... ...and execution of brand strategies that drive brand awareness, market... ...life-changing work. Certified as a Global Top Employer, Takeda offers stimulating...Minimum wageLocal areaRemote work- ...reimagine what finance can do. From strategy through execution, we partner... ...and delivering complex global finance transformations enabled... ...the best by Accenture enabling us to be the #1 Leader in the market... ...strategic client pursuits and lead a complex delivery at rapid...Full timeContract workWork experience placementLive inWork at officeLocal area
$178.5k - $257.83k
Job title: Global Periodic Reporting leadLocation: Cambridge, MA /... ...As Global Periodic Reporting Lead within our Pharmacovigilance team... ...and execute outsourcing strategies, uphold regulatory compliance,... ...innovative pipeline - enables us to invent medicines and vaccines...Full timeWorldwide$148.5k - $214.5k
Job title: US Neurology and Immunology Asset/Indication Lead Location: Cambridge, MAAbout the Job: Sanofi's specialty... ..., value-based contracting strategies, etc.Set HEOR evidence generation... ...pipelinesAlign closely with the Global HEVA team to ensure US insights inform...Full timeContract work$210.9k - $379.2k
...partners worldwide, contributing to global health initiatives.Moderna's commitment... ....Moderna is seeking a Global Medical Lead to lead medical affairs strategy across our Oncology portfolio,... ...Need (Basic Qualifications)MD or non-US equivalent, PharmD, or PhD with extensive...Permanent employmentFull timeWork at officeWork from homeWorldwide$192.4k - $302.39k
...company that will inspire you and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA office.At Takeda, we are... ...with the Global Project Team (GPT) and global brand strategy. This includes incorporating cross-functional strategies (...Minimum wageWork at officeLocal areaRemote work$192.4k - $302.39k
...inspire you and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...according to the PDT Benign Hematology GM strategy in close collaboration with global... ...with Quality, Regulatory, Medical Director.Maintain knowledge base as to developments...Minimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$124k - $186k
...creators to own their own destiny.The Global Onboarding Lead will play a critical role in building and... ...managing details and driving strategy, and you thrive in a small, high-impact... ...salaries for the position across all our US locations. The base salary offered for...Work at office$120k - $225k
...span nearly all segments of the global capital markets. Our... ...investment management firms. With US$1 trillion in assets under management... ...multi-asset, and alternative strategies.As a private partnership whose... ...believe multiple perspectives lead to more informed investment...Full timeContract workLocal areaRemote workFlexible hours1 day per week$234k - $321.75k
About This Role: As the Global Commercialization Lead for SMA, you will play a pivotal role in shaping the commercialization strategy for this key therapeutic area within the Global Product... ...market experience required; 5 years ex-US experience required.Proven experience...Full timeTemporary workLocal area$206.99k - $310.49k
...for providing strategic direction and leading the global drug development with one late stage asset... ...(GPT), which determines the overall strategy for the asset/s across indications. The... ...section in the application form.SummaryLocation: US - Boston - MAType: Full timeFull timeTemporary workWork at officeLocal areaWorldwide- ...OverviewBicara Therapeutics is seeking a Senior Director, Brand Lead - US who will be responsible for developing and executing the US brand strategy and commercial plan for ficerafusp alfa,... .... Founded in 2020, we've built a global team of over 100 employees headquartered...Full timeTemporary workWork at officeLocal area3 days per week
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