- Sumitomo Pharma (Harrisburg, PA)
- …Associate Director Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will ... primarily function as the Regional Regulatory Leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs The base salary range for… more
- Bausch + Lomb (Harrisburg, PA)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work… more
- CSL Behring (King Of Prussia, PA)
- …delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships… more
- Merck (North Wales, PA)
- …Skills:** Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs ... **Job Description** The Associate Director, Regulatory Affairs , supports products in the...and collaboration skills and will work closely with a global regulatory lead(s) to help develop and… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls ( CMC ), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- Organon & Co. (Plymouth Meeting, PA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- J&J Family of Companies (Spring House, PA)
- …teams by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to ... Measurement, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management,… more
- Merck (Upper Gwynedd, PA)
- **Job Description** Global Project and Alliance Management (GPAM) sits in the R&D organization at our Company. GPAM comprises several distinct groups, including ... Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and… 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