- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven 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 of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… 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...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… 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, ... employer. **Job Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Job Title**… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings,...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …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
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible...required to market medical devices in the US The Senior RA Specialist will also support related regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing, managing and improving all aspects of purchasing ... Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC Development partners to ensure supply continuity with optimal...supply continuity with optimal cost and quality. Finally, the Senior Procurement Manager will help drive the… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this....method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more
- ThermoFisher Scientific (Wilmington, NC)
- …people and communities depend on - now and in the future. **Role:** CTM, Senior **Location:** US-Remote, East Coast HIGHLY preferred, may look at Central, but will ... complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical...members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …day and improving the lives of patients for generations to come. As a ** Senior Manager , Global External Manufacturing** at Gilead you will + Support ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. + This… more
- BeOne Medicines (Emeryville, CA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... **General Description:** The Senor Manager , Clinical Supply Chain manages drug supply activities...Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT… more
- Takeda Pharmaceuticals (Boston, MA)
- …reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant ... development and clinical supply processes. + Demonstrated experience authoring CMC sections for regulatory submissions (eg, IND/IMPD/NDA/MAA). +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... data, and drive data-based decisions and solutions. + Experience contributing to regulatory filings for biologics (eg, CMC sections, control strategy… more
- Boehringer Ingelheim (Duluth, GA)
- …or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic and operational...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
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