- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience ... and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and external stakeholders . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, ... to shaping and advancing our Chemistry, Manufacturing, and Controls ( CMC ) strategy **Job Responsibilities** Essential duties and responsibilities include the… more
- Lundbeck (Deerfield, IL)
- …effective regulatory affairs cross-functional team on key labelling requirements ( CMC , Regulatory Operations, US Labeling and Advertising and Promotion, ... Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location:...in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- AbbVie (North Chicago, IL)
- …as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing ... is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation,… more
- Pfizer (Collegeville, PA)
- …on clean and accurate data. + Lead open communication pathways with TA aligned Regulatory and CMC Strategy partners, including GRS Data Owners to ensure ... communities of practice and culture of inclusion **ORGANIZATIONAL RELATIONSHIPS** + Regulatory & CMC Strategy, Clinical, Non-Clinical, Labelling Data… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and analytical testing… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …antibody drug conjugates with scale-up knowledge is required + Experience with CMC regulatory activities in relevant areas such as analytical characterization, ... relevant conjugation chemistries and to transition bioconjugation processes from research to CMC development, as applicable, to champion manufacturing in support of … more
- Adecco US, Inc. (Morristown, NJ)
- Adecco Healthcare & Life Sciences is seeking a skilled ** CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle management ... relevant experience level **Key Responsibilities:** + Author and develop CMC sections of regulatory dossiers (Modules 2 and 3) for development and post-approval… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more