- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external ... decisions.ResponsibilitiesActs as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another… more
- Genmab (Plainsboro, NJ)
- …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 primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned...products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for the assigned… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Director , DSPV Gene Therapy Safety Lead will be the safety expert for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical...Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
- Genmab (Plainsboro, NJ)
- …attitude to drive solutions and inspire others.You will join a highly competent global team focused on packaging and labeling clinical trial supplies, ... and a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities… more
- Takeda Pharmaceuticals (Boston, MA)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director , Global Labeling Strategist, plays a critical role in ... labeling documents that drive differentiation and compliance in global markets. ** Global Labeling Strategy & Execution** + Lead development of… more
- J&J Family of Companies (Raritan, NJ)
- …will be considered as a single submission. We are currently seeking an Associate Director , Global Labeling Product Leader. This position can be located ... in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director , Global Labeling Product Leader will be responsible for the following: + Lead the… 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
- Sanofi Group (Bridgewater, NJ)
- **Job Title** : Senior Director , Global Regulatory Advertising and Promotion Therapeutic Area Head **Location:** Bridgewater, NJ / Cambridge, MA (must adhere to ... for future leadership roles. You will also provide input into the global organization for promotional strategies, including launch strategies. Additionally, you will… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Regulatory Affairs Director - Global Regulatory Lead** **What you will do** Let's do ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA)… more
- J&J Family of Companies (Raritan, NJ)
- …development programs, risk/benefit assessments, and medical affairs programs. + Provide integrated global labeling and filing strategies for assigned projects + ... **We are searching for the best talent fo** **r Director , Global Regulatory Leader** **to be in...Regulatory Team (GRT):** + Serve as a member of Labeling Working Group (LWG) to build or update the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC) - Virology** **KEY ... RESPONSIBILITIES:** Executive Director , Global Clinical Supply Chain is responsible...the long-term vision of optimal supply chain strategies including labeling and distribution activities. + Responsible for risk balancing… more
- Lilly (Indianapolis, IN)
- …Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear and ... $162,000 - $237,600 **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global ...in terms of the program's value proposition, workflow, product labeling , risk management, and issues management. Accordingly, the GRL… more
- AbbVie (South San Francisco, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling ...of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The 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
- Amgen (Los Angeles, CA)
- …and transform the lives of patients while transforming your career. **Executive Medical Director , Global Development Lead** **Live** **What you will do** Let's ... scientific leadership and input into: + Key regulatory/safety deliverables (eg, core labeling and global regulatory submission documents, periodic safety update… more
- BeiGene (San Mateo, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory strategies for ... 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
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