- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... leading the development and maintenance of global labeling documents (eg, Core Data Sheet,...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling , Policy and Intelligence. The position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... party collaborators The position may manage a team of Global Labeling Leads (GLLs) and/or serve as...or a team of GLLs to ensure alignment of labeling content and strategy and to optimize… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... party collaborators The position may manage a team of Global Labeling Leads (GLLs) and/or serve as...or a team of GLLs to ensure alignment of labeling content and strategy and to optimize… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key ... to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content....approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing… 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 cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... party collaborators The position may manage a team of Global Labeling Leads (GLLs) and/or serve as...or a team of GLLs to ensure alignment of labeling content and strategy and to optimize… more
- AbbVie (Irvine, CA)
- …pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for ... TA knowledge and ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as… more
- AbbVie (Mettawa, IL)
- …consortiums, key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA ... negotiations in collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies.… more
- Amgen (Washington, DC)
- …the lives of patients while transforming your career. **Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular)** **What you ... global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions, and + Provide regulatory expertise… 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 In ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can...CMC-Regulatory Affairs strategy , commercial and market access strategy , and the Target Product Profile (for global… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as 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...who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on… more
- BeiGene (San Mateo, CA)
- …and recommend regulatory strategy . Externally, the individual will develop the global strategy for interaction with Health Authorities and will interface ... The Executive Director , Global Regulatory Portfolio Lead will...and regulations. + Integrates market needs and prioritization into strategy development. Expertise in global strategy… more
- BeiGene (Emeryville, CA)
- …sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...regulatory issues and to expedite approvals of product and labeling changes. + Maintains awareness of global … more
- Merck (Rahway, NJ)
- …their results, document disclosure, and data sharing with external researchers. The Senior Director of Global Health Literacy & Health Equity is the enterprise ... Determinants of Health (SDoH) and Health Equity. The position is global in scope. **Internal-Facing Responsibilities** + Provide strategic leadership in health… more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **Regulatory Affairs Director - Global Regulatory Leader - Oncology** **Live** **What you will do** ... Affairs Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and… more
- Takeda Pharmaceuticals (Boston, MA)
- … (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy . + Establishes and drives development team strategy ... Director - Hematology, Neuroimmunology & Specialty Care (HNSC) leads and drives strategy for the overall global (US/EU/Japan/ other regions and countries)… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Global Project Team to ensure that the clinical team activities are aligned with the global strategy . + May act as Global Clinical Lead for an early or ... contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for clinical studies focused on… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …bold mission **OBJECTIVES:** + The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into ... your future at Takeda. Join us as a Medical Director - GI & Inflammation- Rheumatology, in our Cambridge, MA...Team to ensure that activities are aligned with the global strategy . + Establishes and drives Development… more
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