- Lilly (Philadelphia, PA)
- …solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager , Manager - CMC Regulatory is responsible ... for the preparation and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC , Commercial Manufacturing, etc.) to define and ... to market application approvals (BLA, NDA) in partnership with CMC Team Project Manager . + Accountable for...optimize PDs impact within the broader portfolio. + Influences CMC regulatory strategies and critically reviews relevant… more
- Deloitte (Stamford, CT)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… more
- Abeona (Cleveland, OH)
- …commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional ... We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic...working with technical operations or similar groups and has CMC experience within the pharmaceutical or biotech industry. The… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care Apply Now **Mission Statement** Michigan Medicine improves the health of patients, populations, ... process and strives to meet budgetary expectations. Actively participates in regulatory compliance activities. + Coordinates use of exam/procedure room space.… more
- UTMB Health (Tennessee Colony, TX)
- CMC Medication Aide Student Trainee - Michael Unit **Tennessee Colony, Texas, United States** **New** Allied Health UTMB Health Requisition # 2504653 The mission of ... + Assists with patient activities and care as assigned by the nurse manager /designee as indicated by the patient's plan of care. Maintains patient care areas… more
- AbbVie (North Chicago, IL)
- …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Deloitte (Columbus, OH)
- …health Recruiting for this role ends on 8/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more