- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies ... Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements.… 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 ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… 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 ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… 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 ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.ResponsibilitiesResponsible ... 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)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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 ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and related materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the ... 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
- J&J Family of Companies (Titusville, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , ... supports their efforts to have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T Therapy will be responsible… more
- Sanofi Group (Bridgewater, NJ)
- …advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs (RA) serves...and long-term business objectives while mitigating risk. Consults with senior management and provides input to the global… more
- AbbVie (Branchburg, NJ)
- …Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director , Director , or Senior Director ), in the development and ... LinkedIn. Job Description Purpose: Responsible for the development and implementation of global regulatory strategy and representation of Regulatory Affairs… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …oversight of our clinical development programs, ensuring they meet the highest scientific and regulatory standards. The Senior Director will also play a key ... Job Title Senior Director , Clinical Development & Medical...effectively in a multidisciplinary team. + Experience working with global regulatory agencies. + Demonstrated business acumen… more
