- Merck & Co. (South San Francisco, CA)
- Job DescriptionHealth Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZThe Health Systems Oncology Medical Affairs ... organizations.The HSO MAD provides accurate information across the full oncology product portfolio, clinical science, and quality management in...resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs , and other members of… more
- Guardant Health (Palo Alto, CA)
- …aims to address the needs of individuals eligible for cancer screening.The Senior Director , National Field Medical Affairs , Oncology , is responsible for ... Senior Director , National Field Medical Affairs , OncologyFull-timeGuardant... Affairs , OncologyFull-timeGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through… more
- Archer Hires (Santa Monica, CA)
- Medical Director Medical Affairs Oncology / HematologyFull-timeTransition from medical practice to BioPharma Industry Clinical PhysicianReal work/life ... clinical trials as a Principal Investigator or Co-Principal Investigator is required.Medical Affairs Medical Director Oncology / HematologyBiopharma Company,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs .-Preferred: MS with minimum of 8 years of relevant … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US,...in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... 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. (Bernards, 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. (Bernards, 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. (Bernards, 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...diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead… 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
- BridgeBio Pharma (San Francisco, CA)
- Director /Sr. Director , Regulatory Affairs Calcilytix San Francisco, CA/Hybrid Regulatory Affairs Calcilytix Therapeutics, an affiliate of ... regulations, and may interact with health authorities. In conjunction with regulatory affairs leadership, they will develop strong relationships, collaborate,… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills.The Director , Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . Excellent organizational skills and ability to work on… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ... field, advanced degree preferred.At least 8+ years of regulatory affairs experience for the associate director or 10+ years of Regulatory affairs … more
- Monte Rosa Therapeutics (Boston, MA)
- …to join our team as an Associate Director of Regulatory Affairs . This role will focus on oncology , immunology, and related therapeutic areas. The ... support the global development and approval of our innovative therapies.ResponsibilitiesThe Associate Director of Regulatory Affairs will be responsible for… more
- AstraZeneca (Boston, MA)
- …and commercialization of products across both small molecules and biologics within the Oncology Regulatory Science and Strategy (ORSS) group. This role will ... sharing the best submission practices and knowledge. Effectively represent the Global Regulatory Affairs function in senior level interactions at internal… more
- Scismic (Boston, MA)
- …that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the company. ... Sciences, Pharmacy or related field is required; Advanced degree or certificate in regulatory affairs is preferredMinimum of 6 years of direct regulatory… more
- Neogene Therapeutics (Santa Monica, CA)
- …hybrid, and based in Santa Monica, CA and reports to the Executive Director , CMC Regulatory Affairs .ResponsibilitiesInterpret global regulations and guidance ... At AstraZeneca's Oncology R&D division, we follow the science to...achieve the next wave of breakthroughs.Position SummaryThe AD CMC Regulatory Affairs supports the development and successful… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …important to us as an organization.The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support ... all ORIC's clinical development programs of oncology products. This position involves working closely with cross-functional colleagues including regulatory … more
- Daiichi Sankyo, Inc. (Bernards, 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...around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
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