- Parexel (Harrisburg, PA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings… more
- Organon & Co. (Plymouth Meeting, PA)
- …+ Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification?of? ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing… more
- Organon & Co. (Plymouth Meeting, PA)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... 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
- 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
- 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
- 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)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Sumitomo Pharma (Harrisburg, PA)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- 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
