- 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
- Katalyst HealthCares and Life Sciences (Matthews, NC)
- Responsibilities: The Senior Manager , Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, ... teams to meet technical writing and submission management objectives. Support the CMC regulatory writing for high-quality and compliant regulatory … 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
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). A ... The Associate Manager , Clinical Drug Supply & Logistics provides support...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more
- BridgeBio Pharma (San Francisco, CA)
- …focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Sr. Manager , Quality Systems Management will report to the Vice President of Quality, ... CMC tasked with a wide range of responsibilities that...quality management systems (QMS) to ensure compliance with GxP regulatory standards and company policies. This position will also… more
- Xaira Therapeutics (Brisbane, CA)
- …IND filing. Deep understanding of biologics R&D processes, including nonclinical, CMC , and regulatory components. Strong analytical, planning, and organizational ... are seeking a highly skilled and proactive Associate Director, Research Project Manager to oversee the planning and execution of biologics projects from early-stage… more
- Clinical Management Consultants (New York, NY)
- …will be an integral part of our team, reporting directly to the lab manager . Your role will include overseeing day-to-day lab operations, using data analysis to ... monitor performance, and ensuring compliance with regulatory and institutional standards. You will be pivotal in...potential and elevate your career by connecting with a CMC recruiter today! Apply now and become a key… more
- 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
- 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
- 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)
- …finished product. As a team member in interdisciplinary product development teams (eg, CMC teams), the Senior Manager is responsible for early identification and ... AbbVie R&D functions and external partners. Responsibilities: + QA representative for CMC product development teams to facilitate the approval of drug to clinical… 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
- 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
