- BeOne Medicines (Emeryville, CA)
- …Clinical Development, Clinical Operations, Global Statistics & Data Science, Safety, Regulatory , CMC , Portfolio). + Hands-on experience with modern data ... data into a strategic asset. You will be responsible for delivering high- quality , reusable, and governed cross-domain operational data foundations, as well as… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality ... and Controls ( CMC ) business function.** **The role ensures compliance with regulatory standards and drives quality excellence across GRA processes. In… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... regulatory strategies in collaboration with other regulatory , Manufacturing, Quality and project personnel to… more
- Lilly (Indianapolis, IN)
- …all over the world. The Senior Advisor /Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... regulatory strategies in collaboration with other regulatory , manufacturing, quality and project personnel to… more
- Lilly (Indianapolis, IN)
- …across internal CMC networks (Drug Product Delivery, Project Management, Quality , Manufacturing, and Regulatory ) to implement and deliver material and ... (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected + Experience with… more
- Lilly (Indianapolis, IN)
- …to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies. + Engage the external ... with other Lilly chemists, analytical chemists, bioconjugation scientists, engineers, CMC project management, Lilly manufacturing partners, and regulatory … more
- Lilly (Indianapolis, IN)
- …procedures, data requirements and summaries. + Author technical reports and CMC related documents including sections in regulatory submission documents ... through the use of mechanistic thinking, modeling and data rich experimentation. The Advisor / Senior Advisor will collaborate with a diverse cross-functional… more
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... CMC and clinical/non-clinical, labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key… more
- Lilly (Indianapolis, IN)
- …of technical information with, but not limited to, Safety, Environmental and Quality Team members, Purification Development colleagues, CMC Team members, ... members, Analytical Services, Tech Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel. Especially important, in this role,… more
- Catalent Pharma Solutions (Kansas City, MO)
- …inspection readiness; + Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site ... Director is the business partner to Operations and advisor to the General Manager of the site. Location:...Quality Control related procedures; + Maintain an effective Quality Management System (QMS) that aligns with regulatory… more
- J&J Family of Companies (Malvern, PA)
- …strategic implications for TDS. + Collaborate extensively across functions - including Regulatory , Quality , Commercial, and others - to ensure integrated ... (TDS) organization. This role sits at the nexus of CMC , Device Development, and Clinical Supply Chain teams, as...pipeline of strategic leadership. + Serve as a trusted advisor to the VP of DOS and TDS leadership,… more
- AbbVie (Irvine, CA)
- …(Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial ... and present data to Pipeline Governance and senior management. + Strategic advisor to cross-functional teams (eg, Global Commercial Team, Global Brand Team, … more
- Sanofi Group (Northborough, MA)
- …requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience with ... Assesses the availability of materials. + Collaborate with the quality team to secure the release on-time for third...+ A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical + materials in alignment with… more
- Houston Methodist (The Woodlands, TX)
- …and other performance measures associated with certification programs and other regulatory , national, regional or locally- sponsored quality programs. Provides ... and interprofessional healthcare team to facilitate and maintain compassionate, efficient quality care and achievement of desired treatment outcomes. The CM… more
