- Daiichi Sankyo, Inc. (Bernards, 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
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** - Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling ... products. + Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice + Exceptional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently ... provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global Labeling creates, updates, and maintains… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... You will provide strategic input and management oversight of regulatory labeling activities for multiple products across...new therapeutic areas. + Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for the ... with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device… 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 ... Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global ...team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + ... - open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead… more
- Amgen (Washington, DC)
- …and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will do** Let's ... Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory … more
- Lilly (San Francisco, CA)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead ... (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the...regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …of where they live or their economic status. **POSITION OVERVIEW:** As a Sr. Director , Early Oncology Global Regulatory Affairs, you will develop and ... Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise...Strategy Teams. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead ... (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the...regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- PCI Pharma Services (Bedford, NH)
- …pioneer and shape the future of PCI. The Manager, Visual Inspection, Packaging, and Labeling reports directly to the Director of Operations. This role is ... Life changing therapies. Global impact. Bridge to thousands of biopharma companies...packaging technicians, ensuring timely product inspection, documentation, bulk packing, labeling , and shipping of sterile clinical and commercial products… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... with a focus on gastrointestinal (GI) indications and a global regulatory remit. **Responsibilities:** + Provides high...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory… more
- Bayer (NJ)
- …developing US labeling (eg USPI) and packaging in close collaboration with the GRS, Global Regulatory Affairs Labeling , US Ad Promo, and the US business ... to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The ...Country Divisional Heads as well as those of the Global Regulatory Head and R&D organization. Inspires… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Join Kite and help create more tomorrows. **Job Description** The Senior Director , Regulatory Affairs, Advertising and Promotion is responsible for developing ... and executing a regulatory strategy that enables the global business...Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs. **Responsibilities:** + Lead,… more
