- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC ) to keep processes, procedural documents and supporting job… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements ... plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and...and FDA guidelines relevant to device and combination product CMC aspects of product development. Ability to manage complex… more
- Software Placement Group (White Plains, NY)
- Registered Nurse Care Manager The role of the RN Care Manager is integral to our patient care strategy. This position involves performing initial comprehensive ... and effective discharge planning to prevent readmissions. The RN Care Manager ensure coordination of care through intra-hospital and inter-hospital levels,… more
- Eli Lilly and Company (Lebanon, IN)
- …a successful startup into GMP manufacturing operations. Position Description: The CMC Project Management Professional is responsible for overseeing the Chemistry, ... Manufacturing, and Controls ( CMC ) activities for our pharmaceutical products. This role requires...portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial product manufacturing knowledge,… more
- University Hospitals (Cleveland, OH)
- …at UH Cleveland Medical Center! University Hospitals Cleveland Medical Center (UH CMC ) is seeking a dedicated and collaborative Supervisor of Clinical Pharmacy ... care, Level I trauma center. Working closely with the Manager of Clinical Operations, the Supervisor will help lead...with vision and drive. Why Join Us? At UH CMC , you will be part of a dynamic and… more
- Kelly Services (Winston Salem, NC)
- **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... **Position Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to provide specialized support for… more
- AbbVie (Waltham, MA)
- …Tik Tok (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… more
- Gilead Sciences, Inc. (Foster City, CA)
- …knowledge, with manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends. **Basic ... This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and… 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager , CMC Development and Dossiers **Location** : Morristown, NJ **About the Job** The Manager , CMC Development and Dossiers is ... content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and...the authoring of CMC dossier content for regulatory submissions and quality documentation. This is conducted ensuring… more
- AbbVie (Irvine, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager - CMC Dossier Strategy & Leadership participates in ... scientific and technical quality that are compliant with global regulatory requirements. They partner with CMC teams...with global regulatory requirements. They partner with CMC teams during the development of early-phase CMC… 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
- 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. (Bismarck, ND)
- …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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… more
