- Lilly (Philadelphia, PA)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Overview:** The 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 globally.… more
- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… more
- Sanofi Group (Morristown, NJ)
- …finds the root cause, sets-up corrective action plan and/or proposes alternate solutions. + Regulatory CMC Manager / PFP is independently responsible for ... CMC responsibilities. Communication should be proactive and timely. **Planning/Coordination:** The Regulatory CMC Manager will work jointly with GBU /… 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
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory ... are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day might include the… more
- Deloitte (Chicago, IL)
- …(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
- Charles River Laboratories (Rockville, MD)
- …build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. Responsible for ... mapping resource across projects. In this role, the Senior CMC Project Manager is the key interface...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… 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
- Cardinal Health (Dover, DE)
- …to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for ... Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical… more
- UTMB Health (Jacksboro, TX)
- CMC Medication Aide Student Trainee - Telford Unit **Jacksboro, Texas, United States** **New** Allied Health UTMB Health Requisition # 2503331 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
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