- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Global Regulatory Lead **Location** : Bridgewater, NJ / Cambridge, MA (hybrid) **About the Job:** Are you ready to shape the future of ... accelerate progress. Join our Immunology & Inflammation Regulatory Team as Global Regulatory Lead and you'll be responsible for the development &… more
- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a member… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- CSL Behring (King Of Prussia, PA)
- …of new therapies and technologies to patients. + In specific instances when serving as a Global Regulatory Lead (GRL) - EHT, acts as the primary ... and compliance throughout the process. + In specific instances when serving as a Global Regulatory Lead (GRL), acts as the primary regulatory interface… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Merck (North Wales, PA)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... and the delivery of targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single… more
- J&J Family of Companies (Spring House, PA)
- …plan, risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including ... leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of… more
- Bristol Myers Squibb (Princeton, NJ)
- …of key messages. The GBDS Lead typically represents GBDS in meetings with global regulatory agencies. The GBDS Lead has accountability for the ... is a core member of the development team. Along with the clinical and regulatory leads, the GBDS Lead is responsible to provide scientific and strategic… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... partners such as Global Regulatory Compliance, Global Labeling,...conducive to goal achievement. + Must be able to lead cross-functional and cross-regional teams and deliver results in… more
- CSL Behring (King Of Prussia, PA)
- …to treat serious and often rare conditions. Could you be our next Associate Director, Global Regulatory Affairs? The job is located in our King of Prussia PA ... hybrid position. You will report to the Director of Global Regulatory Affairs. **Responsibilities:** You are a...and best practice. Be a delegate for the TA lead . + Leading the establishment and maintenance of high-quality… more
- Bristol Myers Squibb (Princeton, NJ)
- …through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute ... and Health Authorities. Develop & communicate strategic direction based on global regulatory guidelines and experience. **Position Responsibilities** In addition… more
- Sanofi Group (Bridgewater, NJ)
- …science partners to uncover insights for customer engagement optimization. + Lead Global /Affiliate co-creation and ensure local understanding/ implementation of ... **Job title** : Global Customer Engagement Lead **Location** :...with Sanofi Specialty care leadership, Sanofi Digital Accelerator, IT, Global Commercial and Medical Leadership, Regulatory , Medical… more
- Novo Nordisk (Plainsboro, NJ)
- … Safety Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East… more
- Sumitomo Pharma (Trenton, NJ)
- …+ As a Regional Regulatory Lead , manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) + As ... Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in...(GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory … more
- Sumitomo Pharma (Trenton, NJ)
- …As a Regional Regulatory Lead , manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) + ... Affairs** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in...skill-set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaison with local… more
- Taiho Oncology (Princeton, NJ)
- …be assigned to lead /support one or two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution ... affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides ...well in a team environment and the ability to lead and influence others. + Ability to: + Read,… more
- Bristol Myers Squibb (Princeton, NJ)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more
- Nestle (Bridgewater, NJ)
- …brands, and pharmaceutical therapies, we are redefining the management of health. The Global Marketing Lead /Director, Solgar will lead the development and ... diverse context. **A day in the life of a Global Marketing Lead /Director, Solgar** + Define consumer...+ Understanding of the health & wellness market and regulatory dynamics + Leadership experience in managing and developing… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC...documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory … more
- Cardinal Health (Trenton, NJ)
- …labeling, meeting documents, and product dossiers. + Ensure alignment with global regulatory requirements for clinical trials and marketing applications. ... experience with demonstrated leadership responsibilities, preferred. + Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.) and clinical… more