- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and ... in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: May 13, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible for influencing department … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …in translational medicine (T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is ... Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets within...evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies… more
- Takeda Pharmaceuticals (Exton, PA)
- …role clarity with other interfacing Takeda functions, including but not limited to Global Medical Affairs , commercial business units, regulatory , medical ... in all phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). +… more
- J&J Family of Companies (Spring House, PA)
- …clinical pharmacology, biostatistics, data science, medical writing, clinical operations, medical safety, regulatory affairs , quality, medical ... protocols, case report forms, operational & analytic plans + Execution: regulatory / ethics committee applications, start-up, enrolment, medical monitoring,… more
- J&J Family of Companies (Horsham, PA)
- …including Marketing, Strategic Customer Group, Strategic Insights & Analytics, Field sales teams, Medical Affairs , Regulatory , Legal, and outside vendors to ... (professional promotion, market access, and customer experience) for two medical benefit Immunology brands + Lead and develop innovative direct-to-consumer… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …to serve as a clinical/ medical scientific consultant to health economic, medical affairs , marketing, regulatory , statistical and other research project ... including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing. + Experience with the global regulatory … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …to serve as an clinical/ medical scientific consultant to health economic, medical affairs , marketing, regulatory , statistical and other research project ... and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not… more
- Pfizer (Collegeville, PA)
- …launch and lifecycle management preferred. + Experience interfacing/collaborating with field sales, medical affairs , regulatory , and supply. + Strong ... success working with multiple stakeholders, including the broader franchise team, CMO, medical , market access, agency partners, and other cross functional cohorts. +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …collaborate closely with cross-functional teams, including Brand Marketing, Sales, Patient Access, Medical Affairs , and Regulatory , to integrate pharmacy ... materials, patient support, and engagement strategies. + Work with sales, medical affairs , and market access teams to ensure smooth integration of pharmacy… more
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