- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... 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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- Drive Labeling Strategy , in-line with overall global regulatory strategy , by providing labeling expertise for Company Core Data Sheet (CCDS), USPI ... negotiation strategies. + Support global HA interaction strategy to discuss key labeling elements. +...facilitate final label negotiations and approval. + Present to Global Labeling Review Team: Ensure Core Data… 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 cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …of end-to-end labeling processes and systems. **Job Description** + Act as Global Labeling Strategy Lead, supporting preparation, review, and update of ... to drive alignment of labeling content and strategy . + Partner with Global Regulatory Affairs...all labeling is aligned with the product global strategy and key messaging. + Evaluate… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy is ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the… more
- Lundbeck (Deerfield, IL)
- …+ Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + Knowledge of development and registration ... Director US Regulatory Global Strategic Labelling...labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …global clinical supply chain-including forecasting, planning, packaging and labeling operations, IRT/RTSM strategy , distribution, cold-chain management, depot ... Sr. Director , Global Clinical Supply Chain, GCO...Clinical Supply Operations** 1. Oversee forecasting, demand planning, supply strategy , packaging, labeling , and global … more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear and… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …their aspirations. Join Kite and help create more tomorrows. **Job Description** **Executive Director , Global Supply Chain, Head of Planning** Everyone at Kite ... in our mission! We are looking for an Executive Director of Global Supply Chain, Head of...Labeling operations. Serves as advocate to shape CMC strategy and product decisions, deliver TechOps readiness for clinical… more
- AbbVie (Mettawa, IL)
- …brand strategy + Determine, in collaboration with cross functional leaders, the global development strategy for new or marketed products and contribute to ... global team environment. Ability to interact externally and internally to support global business strategy . Additionally, this person must be able to interact… more
- Amgen (Washington, DC)
- …other innovative, driven professionals in this meaningful role. **Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity** **Live** **What you ... global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions + To provide Regulatory leadership… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Strategy Requisition ID: 7214 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the challenges are ... the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With...- Open to candidates within the United States** The Director , US Regulatory Affairs Strategy , oversees the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading clinical...who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on… more
- J&J Family of Companies (Raritan, NJ)
- …expertly representing market access within Compound Development Team and other global strategy teams, building strong relationships and effective collaboration ... of America, Raritan, New Jersey, United States of America **Job Description:** ** Director , Global Compound Market Access Leader, GU Oncology Early Pipeline… more
- BeOne Medicines (San Mateo, 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
- J&J Family of Companies (Raritan, NJ)
- …expertly representing market access within Compound Development Team and other global strategy teams, building strong relationships and effective collaboration ... patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Global Commercial Strategy Organization, a group within Janssen … more
- Sanofi Group (Morristown, NJ)
- …and setting clear expectations for the device regulatory strategy , including a global labeling strategy + Ensures alignment and communication internally ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are… more
- ThermoFisher Scientific (Wilmington, NC)
- …illness and evaluate patient outcomes, preference and/or adherence, while supporting promotional and labeling claims on a global scale. This is a fully remote, ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...be a recognized expert in Clinical Outcome Assessments (COA) strategy with high external visibility and strong track record… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... Sciences team for the US business, the Associate Medical Director supports the US Medical Director for...and implementation of the product medical and medical launch strategy as well as working intricately within the other… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …guidelines. Organizational Relationship/Scope: + This position reports to the Head of Global Medical Affairs. The Senior Medical Director will interact with ... Global Medical Department, Marketing, Sales, Research and Development, strategy /portfolio management, Regulatory Affairs, and Pharmacovigilance. External collaboration includes… more