- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local ... new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Lilly (Durham, NC)
- …people management experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. + Prior experience with common ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Lilly (Indianapolis, IN)
- …people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Taiho Oncology (Pleasanton, CA)
- …USPI, CCDS, IB, SmPC, and others) are current, accurate, and compliant with global regulatory requirements for ICSR assessments. The position also supports PV ... we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other....Operations through regulatory intelligence review and the configuration and testing of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as ... **Job Description** **POSITION OVERVIEW:** You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in… more
- BeOne Medicines (San Mateo, CA)
- …ICH-GCP (International Council for Harmonisation - Good Clinical Practice) + EMA and global regulatory authority expectations + PhRMA Code, EFPIA Code, IMI, and ... Strong understanding of global clinical development, research operations, and global regulatory frameworks. + Prior experience advising Global R&D or… more
- Lilly (Raleigh, NC)
- …people management experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. + Experience leading a major ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Takeda Pharmaceuticals (Lexington, MA)
- …requirements. * Comprehensive understanding of Good Manufacturing Practices (GxP), global regulatory expectations, and experience with Health Authority ... various functions across Takeda, including Data Governance, Computerized Systems Quality, Global and Operational DD&T functions, Regulatory Affairs, and… more
- Trexquant Investment (Stamford, CT)
- …for separately managed accounts + Advise on financial market and global trading regulatory obligations, including filings, cybersecurity requirements, and ... and related SEC regulatory regimes. + Deep understanding of US and global security regulations, including SEC, CFTC, NFA and FCA frameworks + Strong grasp of… more