- 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
- Actalent (Lake Forest, CA)
- …highlighting technical qualifications Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory ... Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs , FDA CFR, CMC , manufacturing controls, RAC… 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
- Sanofi Group (Morristown, NJ)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… more
- Sanofi Group (Cambridge, MA)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Lilly (Indianapolis, IN)
- …chemistry or related scientific discipline) + 3 years industry-related experience in regulatory affairs , CT Labeling and/or drug development + Knowledge of ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...Delivery organization, external clinical and regulatory vendors, regulatory colleagues in GRA, GOLD, and GRA- CMC … more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing ... best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About the role:**… more
- Boehringer Ingelheim (Duluth, GA)
- …vision or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with ... of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate...Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic… more
- Organon & Co. (Jersey City, NJ)
- …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