- Parexel (Harrisburg, PA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our ... in developing contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional project meetings and provide … more
- 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
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs , Clinical, and Program Management.Maintain ... from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director, Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The individual ... application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed. **Required Education,… more
- Merck & Co. (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
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships… 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
- 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
- Parexel (Harrisburg, PA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our ... in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and provide … more
