- Genmab (NJ)
- …you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. Advances this effort through ... leading cross functional teams to develop, validate and refine allocation strategy , inclusive of timelines, scenarios, and risk mitigation plans.Identifies and… more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop recruitment strategy… more
- Merck & Co. (North Wales, PA)
- …and unplanned statistical analyses.Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and ... data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes; and ability to efficiently manipulate very large databases… more
- Bausch Health (Bridgewater, NJ)
- …on new product opportunities. Key Responsibilties: + Responsible for developing a product regulatory strategy for pharmaceutical products + Liaise with ... approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory … more
- Bausch Health (Bridgewater, NJ)
- …of the product development team to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory strategy components and ... on new product opportunities. Key Responsibilities: + Responsible for establishing a product regulatory strategy for pharmaceutical products in the assigned… more
- Fresenius Medical Center (Waltham, MA)
- …of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... the pharmaceutical industry. + Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing ... CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position… more
- Bausch Health (Bridgewater, NJ)
- …support compliance. Key Responsibilities: + Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products + Support ... and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Supports for Brand… more
- Takeda Pharmaceuticals (Boston, MA)
- …This role serves as the single point of contact for R&D CMC Portfolio Strategy enabling activities on behalf of the CMC community within R&D, but also in ... office), portfolio insights and portfolio stakeholder management. + **R&D CMC Strategy Leader & Stakeholder Management:** Accountable for oversight of the Pharm… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reflect Boehringer Ingelheim's high regard for our employees. The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance ... product lifecycle on assigned projects. This role will develop and own the Global Regulatory Strategy for assigned assets, lead the Regulatory Excellence… more
