- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... opinion leader interactions related to the disease area(s); partners with Medical Affairs , Commercial and other functions in these activities as required, consistent… 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 ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Organon & Co. (Jersey City, NJ)
- …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
- Bristol Myers Squibb (Cambridge, MA)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... development and enable continuous improvements without compromising quality. + Engages senior leaders and functional area stakeholders to ensure alignment of program… more
- Sanofi Group (Cambridge, MA)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area Head to provide leadership, supervision, and coordination… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... project's primary point of contact for Pipeline Governance and senior management. + Has a broad vision for the...cross-functional teams (eg, Global Commercial Team, Global Brand Team, CMC , Integrated evidence strategy team, Value and Access team,… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC + Strong knowledge of QbD principles and designing appropriate… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more