- Merck (North Wales, PA)
- **Job Description** The Associate Director, Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team. The ... application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls ( CMC ), medical affairs and business development are critical to the success… more
- Merck (Upper Gwynedd, PA)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... strategic and tactical input from diverse disciplines (eg, Medical Affairs , Outcomes Research, Market Access, Biostatistics and Research Decision Sciences,… more
- J&J Family of Companies (Spring House, PA)
- …Measurement, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, ... by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in the drug development processes for pharmaceuticals (eg project management, CMC , non-clinical, clinical, Regulatory Affairs ). * Experience ... and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents. 5 Define and implement the medical monitoring… more