- Organon & Co. (Plymouth Meeting, PA)
- …the organization's business objectives. + Collaborate with cross-functional teams, including clinical development, regulatory affairs , marketing and sales, ... medical strategies that drive business outcomes. + Strong understanding of clinical development, regulatory requirements, and commercialization processes. +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+ ... value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer...cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time … more
- Sumitomo Pharma (Harrisburg, PA)
- …for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs ... (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre- clinical research, Medical Affairs and Commercial… more
- Bausch + Lomb (Harrisburg, PA)
- …members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs and/or CTMs… more
- Sumitomo Pharma (Harrisburg, PA)
- …products, ensuring continuous benefit-risk assessment. + Collaborate with colleagues in Clinical Development, Regulatory Affairs , Biostatistics, Data ... Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses. + Contribute to signal… more
- Sanofi Group (Swiftwater, PA)
- …+ Collaborates with colleagues mainly from PSPV as well as Pre- Clinical & Clinical Development, Regulatory Affairs , Medical Affairs , Legal and Global ... lifecycle of a broad range of marketed products and innovative therapies in clinical development. We are an innovative global healthcare company with one purpose: to… more
- Merck (North Wales, PA)
- **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the ... regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate...content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory … more
- J&J Family of Companies (Horsham, PA)
- …Medicine R&D is recruiting for a Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This position is a hybrid ... in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of CMC … more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jul 10, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible for influencing department … more
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