- Sanofi Group (Morristown, NJ)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device … more
- Lilly (Indianapolis, IN)
- …sciences and experience in pharmaceutical development to enable clinical trials, regulatory submissions, and new product commercialization. This role offers the ... linker payload component development, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry. + Develop and… more
- Merck (Boston, MA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams. + **Reporting & ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and… more
- University of Colorado (Aurora, CO)
- …Collaborate with investigators, IRBs, research administration, and legal teams to navigate regulatory pathways for novel therapeutics and devices + Convene and lead ... to strengthen those areas. + Evaluate, select, and manage external regulatory consultants supporting translational research initiatives by developing and providing… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- AbbVie (Irvine, CA)
- …(Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial ... advisor to cross-functional teams (eg, Global Commercial Team, Global Brand Team, CMC , Integrated evidence strategy team, Value and Access team, Regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays + ... from Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to drive alignment on potency strategy and successful transfer… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Management Systems (QMS) to assure the site/division is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and ... readiness; + Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan,… more
- Eurofins US Network (Lancaster, PA)
- …This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams ... implement mitigation strategies. + Ensure all deliverables meet client expectations and regulatory requirements. + Prepare and present project updates and reports to… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more