- Genmab (Princeton, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible ... for the development of global and US regulatory strategies to advance Genmab's portfolio...the path to market, as applicable. Collaborate with the Labeling team to develop the Company Core Data Sheet… more
- Genmab (Princeton, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, the regulatory leader will be ... of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab's portfolio of development...submissions of IND, (s)NDA/BLA to US FDA Experience with labeling and PMC/PMR negotiations with US FDA Ability to… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) driving cross-functional collaboration… more
- J&J Family of Companies (Titusville, NJ)
- …- 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader (1 of 2) in ... Associate Director , Global Labeling Product Leader (1 of 2)… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) and facilitates discussions to ensure… more
- AbbVie (North Chicago, IL)
- …and joint company meetings for third party agreements, all under the direction of the Director , Strategic Global Labeling . Leveling of the role is flexible ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager Labeling RA, Strategic Global Labeling , develops and maintains US… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external ... Responsibilities + Acts as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global… more
- Ascendis Pharma (Princeton, NJ)
- …the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with US ... The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for...labeling processes and infrastructure . Work closely with global labeling managers to ensure consistency and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and teams. You will oversee or otherwise lead impact assessments on major global labeling issues. You will oversee or otherwise lead the establishment ... and maintenance of processes for ensuring global labeling compliance based on internal and external standards. You will be a member of the Innovation, Content,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including those involving 3rd party collaborators The position may manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project ... this position mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross-… more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology** **Live** **What you will do** ... Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves as the regulatory...prescription drugs, biologics, and devices. We are an innovative global healthcare company with one purpose: to chase the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …together. **Job Description** As the lead for LIFE therapeutic areas, the Director will oversee the development and delivery of medical information content for ... medical input for promotional and medical review committees. Additionally, the Director will be responsible for business optimization, which may include oversight… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: Jun 20, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...world data studies, surveys, and economic models. The **Senior Director , Pipeline Head for Neuroscience** , will develop the… more
- Organon & Co. (Jersey City, NJ)
- …Description** **The Position** The successful candidate will lead a group of Global Regulatory Leads (GRLs), who are responsible for development and implementation ... of development through registration and mature products. The Executive Director could also support business development due diligence activities.… more
- Merck (Rahway, NJ)
- **Job Description** We are currently recruiting for a ** Director , Global Marketing for Women's Cancer** for the oncology portfolio. The Global Marketing ... commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling , launch readiness reviews, organized… more
- J&J Family of Companies (Raritan, NJ)
- Director , Global Compound Market Access Leader, Hematology (1 of 2 Positions) - 2406198491W **Description** Company Description At Johnson & Johnson, we believe ... profoundly impact health for humanity. Learn more at https://www.jnj.com/. Job Description Global Commercial Strategy Organization, a group within Janssen Global … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will develop and ... execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …is not possible. This job cannot be based in Basking Ridge, NJ._ The Senior Director , Global Marketing will be responsible for global strategic and tactical ... and related new indications). Primary responsibility is to lead development of global marketing strategy for these indications and drive execution of global… more
- BeiGene (Emeryville, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory ... regulatory issues and to expedite approvals of product and labeling changes. + Maintains awareness of global ...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of changes on… more
