- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... area leaders and joint Alliance partners. **Responsibilities** + Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory … more
- AbbVie (Florham Park, NJ)
- …needs. Presents process, strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for setting… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- … global regulatory filings. **How you'll spend your day** The Senior Director : + Will foster relationships with opinion leaders in assigned ... Senior Director Clinical Development - Respiratory...Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global Clinical Operations, development partners and CROs in the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Additionally, this position recommends and executes strategies in collaboration with Senior Management and global stakeholders that are optimized across ... 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
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Medical Director , US Lymphoma/CLL will report to the ... will lead the US medical Lymphoma team supporting the MM/Lymphoma Disease Lead. The Senior Medical Director will provide key contribution for the overall medical… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Biosimilar Strategy Date: Sep 23, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56832 **Who ... on strategic decisions and workload associated with building the department. This Senior Director must have strong relationships and communication skills as… more
- Bristol Myers Squibb (Summit, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director , Risk Based Quality Management leader will work closely ... with the R&D Quality GxP Heads as well as Global Quality, R&D, and Enterprise Risk functons to manage...making, and quality oversight to ensure BMS complies with regulatory requirements. + Previous experience dealing with regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. **This position… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron's...on drug development, operations, and commercialization in all relevant global territories. **In this role, a typical day might… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Associate General Counsel, Transactions Date: Sep 12, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... and new people to make a difference with. **The opportunity** The Sr. Director , Associate General Counsel, Transactions & Corporate Affairs role reports directly to… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Marketing Ajovy Date: Sep 10, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 58082 **Who we ... a difference, and new people to make a difference with. **The opportunity** The Senior Director , Marketing - AJOVY is responsible for creating and driving… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Job Title** Sr. Director , Global Data Management (GDM) Process, Systems and Operational ... Excellence **Division** Research and Development (R&D), Global Drug Development (GDD), Global Development Operations (GDO), Global Data Management (GDM)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Senior Director sits within Global Oncology Clinical Development, an ... 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... define and oversee the translational strategy/plan for oncology therapeutic program/s in global R&D. The successful candidate will set goals and enumerate key… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Integrated Supply Planning - Foster City, CA Based ... the company and the various governmental agencies. Directly interfaces with regulatory agencies as required. + Coordinates interdepartmental activity with Quality… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Regeneron global PV system, including but not limited to: Global Patient Safety (GPS), Medical Affairs, Regulatory , Commercial, etc. + Participate ... and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager...a quality perspective in conjunction with business and Associate Director / Director , GVP QML + Engage… more
- Bristol Myers Squibb (Summit, NJ)
- …and R&D Quality roles. + Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and ... process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards. The Executive Director will work… more
- System One (Florham Park, NJ)
- … Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This ... QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory ...meetings related to QOL initiatives. + Support coordination with global regulatory counterparts to ensure alignment of… more