- 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 ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- ICON Clinical Research (Raleigh, NC)
- Senior Manager, Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... IVD Location: US Remote, Portland, OR area preferred We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a… more
- Parexel (St. Paul, MN)
- …go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial. You'll help ... This role is ideal for a candidate with a strong background in regulatory affairs , labelling strategy, and cross-functional leadership. It offers the opportunity… more
- Otsuka America Pharmaceutical Inc. (Oklahoma City, OK)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time ... Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry required- 4 or More… more
- CSL Behring (Waltham, MA)
- Position Title: Senior Manager, Corporate & External Affairs , R&D Portfolio Position Purpose: The Senior Manager, Corporate and External Affairs , R&D ... Portfolio will execute the corporate and external affairs strategy for CSL's pipeline. The successful candidate will...in serving as a business partner and advisor to senior leaders, assisting with the shaping and communication of… more
- Merck & Co. (North Wales, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... for the future of science, we're in. Are you?About the Role:The Senior Director, Medical Services will provide strategic leadership to Insmed's independent medical… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …development programs. Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. Minimum of 5 years of regulatory affairs experience. Minimum 2-3 years' work experience in regulatory… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose job will ... and managing Eisai's US Privacy Program, the responsibilities of the Associate Senior Counsel, Privacy, include, but are not limited to, practical and timely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred 7+ years of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...or biotechnology industry. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations… more
- Merck & Co. (South San Francisco, CA)
- …(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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Boston, MA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to the development and implementation ... the strategic plan for their assigned therapeutic area. In addition, the Senior Medical Information Manager leads cross functional teams and initiatives to support… more
- Lilly (Durham, NC)
- …include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs Additional Preferences: Broad knowledge of GMPs ... for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory , Global Patient Safety, Qualified Persons at… more
- Insmed Incorporated (NJ)
- …alignment of US HCP activities with field execution.Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial Operations ... other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our TPIP program in Pulmonary Hypertension… more
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