- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Sumitomo Pharma (Raleigh, NC)
- …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
- Chiesi (Cary, NC)
- …valuable feedback. Who we are looking for This is what you will do As a Regulatory Affairs Intern within Chiesi Global Rare Diseases, you will gain hands-on ... The internship provides a strong foundation for a future career in regulatory affairs , clinical development, or related functions within the biopharmaceutical… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …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
- Parexel (Raleigh, NC)
- …and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge ... to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as...experience is required. * Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. *… more
- ThermoFisher Scientific (Wilmington, NC)
- …language where applicable, both oral and written * Excellent understanding of global /regional/national country requirements and regulatory affairs procedures ... Conditions** Office **Job Description** Join Us as a Director Regulatory Affairs - Make an Impact at...and lifecycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at… more
- Parexel (Raleigh, NC)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life… more
- ThermoFisher Scientific (Greenville, NC)
- …to producing compliant deliverables + Advanced, broad understanding of global /regional/national country requirements/ regulatory affairs procedures for ... trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory … more
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