- 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
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager , Global Regulatory Affairs, CMC Small Molecules where you will ... oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on Regulatory , Pharmaceutical… more
- United Therapeutics (Research Triangle Park, NC)
- …, project teams, and functional area representatives to devise and implement sound regulatory CMC and labeling strategies. + Manage and lead regulatory ... you might be exactly who we're looking for. The Regulatory Affairs Manager will manage and lead...manufacturing and quality groups, contract and partner organizations regarding CMC regulatory issues and provide strategic … 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
- AbbVie (North Chicago, IL)
- …Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Program Manager , CMC Dossier Management assists with the development and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director), you will be responsible for leading and ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- Cardinal Health (Olympia, WA)
- **_What Chemistry, Manufacturing & Control ( CMC ) contributes 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 … more
- UTMB Health (Galveston, TX)
- Cluster Nurse Manager - CMC - Galveston County Jail **Galveston, Texas, United States** **New** Nursing & Care Management UTMB Health Requisition # 2505552 The ... formulation and management. + Ensures facility compliance with institutional, professional, regulatory , and governmental standards. + Assures that all staff are… more
- UTMB Health (Tennessee Colony, TX)
- CMC Medication Aide Student Trainee - Michael Unit **Tennessee Colony, Texas, United States** **New** Allied Health UTMB Health Requisition # 2504655 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
- ThermoFisher Scientific (Grand Island, NY)
- …expectations, and regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers using our materials ... Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager , Regulatory Affairs - Drug Support Strategy...advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC .** **As assigned, supports development of CSL policy positions ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The...Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, IG/EHT (Enabling Healthcare Technologies encompasses… more
- CSL Behring (Waltham, MA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our Waltham MA office. This… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …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
- BMO Financial Group (New York, NY)
- …reserve calculation for BMO Chicago Branch, and as needed assist in CMC regulatory reporting and other financial/statutory reporting matters. Works closely ... Member of the broker/dealer regulatory reporting team who will be responsible for...customers reach theirs. From in-depth training and coaching, to manager support and network-building opportunities, we'll help you gain… more
- Bristol Myers Squibb (Seattle, WA)
- …advanced degree preferred. + PMP certification highly desirable. + Understanding of cGMPs and regulatory CMC . + A minimum of 8 years in BioPharma operational or ... strategies for both early-and late-stage pipeline cell therapies enabling global regulatory approval and launches. The **Senior Manager , Program/Project… more
- Honeywell (Baton Rouge, LA)
- …controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract Manufacturing ... The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems...SOPs, company policies and procedures, safety and environmental and regulatory requirements + Reviews cGMP batch manufacturing and packaging… more
- Cambrex High Point (Longmont, CO)
- …Overview Cambrex is seeking to hire a growth-related Research Investigator & Manager position with a highly motivated individual for the Process Chemistry ... substance manufacturing requirements, and substantial experience with GMP practices, CMC principals and ICH guidelines for pharmaceutical development. Deep knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Regulatory Chemistry, Manufacturing and Controls (RA CMC ),to identify ... oversight forassigned GileadCXO partners/sites. + Assure CXOs meet Gilead's quality, regulatory and compliance standards, to ensure a sustainable delivery of quality… more