- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Organon & Co. (Plymouth Meeting, PA)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… 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
- Sumitomo Pharma (Harrisburg, PA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sumitomo Pharma (Harrisburg, PA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs . The Associate Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- 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
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …precision mental health care. 2. Provides consultation to investigators on all regulatory oversite of the research portfolio and in particular clinical trials. ... and family psychotherapy. 5. Provides consultation to professional staff within CMC VAMC system and to community providers, concerning clinical assessment findings… 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 ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… 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 ... Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Value & Implementation Project Manager (VIPM), is a core member of Value… 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
