- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing ... and directing the regional regulatory strategy , objectives, policies, and programs pertaining...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … impact including execution, leading and lagging metrics that tie to the medical affairs strategy . Update the metrics in a regular cadence based on feedback ... from HCP interactions, patient outcomes and evolution of medical affairs strategy .- Pilot Analytics projects: Evaluate technologies and platforms that support a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr . Director, representing the Quality organization at senior levels. The Director ... and working toward building a quality mindset with Medical Affairs .Support the Sr . Director's Medical Affairs Quality strategy by partnering with members… more
- Merck & Co. (North Wales, PA)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. Apply domain knowledge to ... Clinical Development and Digital Solutions (CDDS) value team, - the Business Strategy Partnership (BSP) organization is seeking a highly motivated Senior … more
- Insmed Incorporated (San Diego, CA)
- … Affairs , lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product developmentMonitor ... of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the ...for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy… more
- Merck & Co. (Rahway, NJ)
- …innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also ... lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions...strategy , risk, mitigation, and overall plan to the Regulatory Affairs , R&D, Manufacturing and GHH management… more
- Insmed Incorporated (NJ)
- …colleagues to align professional and marketing efforts with PAH brand strategy .Cross-Functional LeadershipPartner with Sales, Market Access, Medical Affairs , and ... Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial… more
- Merck & Co. (Rahway, NJ)
- …development strategy , study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May ... Job DescriptionThe Senior Director ( Sr . Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Insmed Incorporated (NJ)
- …Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial Operations ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Senior Manager, PCP Marketing, will lead the development and implementation of primary care ... Functions /Key Responsibilities: Assist the development of the PCP go-to-market strategy Partner closely with cross-functional teams to develop and execute all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Insmed Incorporated (NJ)
- …every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, ... and for the future of science, we're in. Are you?About the Role:The National Senior Director, US Field Medical is responsible for the direct leadership of the… more
- Merck & Co. (North Wales, PA)
- …driver for the US Market and our company.This role will lead the US Launch Strategy and readiness for our Ulcerative Colitis Indication in IBD; a phase 3 monoclonal ... position will be responsible for developing and implementing our US Strategy and promotional campaigns. The incumbent will work closely with cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …potential to dramatically influence stakeholder perceptions. Relationships Reports to the Senior Director, Media & Stakeholder Relations, and interacts with ... senior leaders across all areas of Novo Nordisk US...including USO President/Executive Office, Commercial, Market Access and Public Affairs , Legal, Finance and Investor Relations, Clinical, Medical and… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated...safety, delivery, cost of goods, and budget forecasts.Translate site strategy into IPT annual plans and priorities (hoshin kanri… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Washington, DC. **This position does not offer relocation assistance** **About the role:** The Senior Regulatory Affairs Strategy Specialist will work in ... Affairs at BD Explore innovative solutions in BD Central Regulatory Affairs (RA) - Regulatory Strategy Team. Develop expertise across medical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... product development activities/meetings + Perform research to support the development of regulatory strategy for the assigned clinical development program +… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular ... impact of decisions across functional areas. As a strategic leader within the Regulatory Affairs organization the incumbent will be instrumental in the evolution… more
- Sumitomo Pharma (Providence, RI)
- …CNS assets. **Job Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain approval for ... and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads... regulatory strategy to meet the Company's objectives. + Oversee the… more
