- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in ... oncology , as well as other research areas centered around...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... Ph.D., MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA ... other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs Strategy ( Oncology ) will provide leadership on global regulatory activities for the assigned products. Responsibility ... will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so… more
- Amgen (Washington, DC)
- …change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory ... It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology ** **Live** **What you will… more
- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will...Advanced Degree required. . Minimum of 10 years overall regulatory experience (at least 6 years in Oncology ... and able to have extensive/in-depth interactions with departments outside of regulatory affairs ; ensures timely preparation of Health Authority submissions… more
- AbbVie (North Chicago, IL)
- …skills, both oral and written + Preferred Experience: 5 years in regulatory pharmaceutical affairs + Strong leadership presence with prior management ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (Mettawa, IL)
- …Provides specialist medical/scientific strategic and operational leadership into global oncology pipeline related medical affairs activities including but ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (Mettawa, IL)
- …may be allocated as an senior scientific/medical director or scientific/medical director . Experience in the field of hemato- oncology is strongly preferred. + ... activities with internal stakeholders (eg, commercial, clinical operations, market access, regulatory ) as they relate to on-going medical affairs projects.… more
