- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- Parexel (Providence, RI)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Boehringer Ingelheim (Duluth, GA)
- …product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical biotech and ... Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...initiatives internal to RA CMC . + Represents CMC regulatory affairs on project… more
- Organon & Co. (Plymouth Meeting, PA)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Organon & Co. (Jersey City, NJ)
- … product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… more
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