- 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
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing ... activities related to developmental or commercial compounds, with supervision. Represent Regulatory CMC on cross-functional development/commercial teams and … 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
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …sites, when required. Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing ... pending and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can...of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff,… more
- Amylyx Pharmaceuticals (Cambridge, MA)
- …improvement of QC operations internally and at external CMOs/CTLs. Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial ... apply. THE OPPORTUNITY The Quality team is expanding and looking to hire a Manager of QC/AD, reporting to the Director of QC/AD. This individual will be responsible… more
- Advocate Aurora Health (Charlotte, NC)
- …time Benefits Eligible: Yes Hou rs Per Week: 40 Schedule Details/Additional Information: Weekdays CMC serves as the region's only Level 1 trauma center and is an ... for 7 years in a row. Also located at CMC is Levine Cancer Institute's academic and research headquarters,...employees are in compliance with the Nursing Practice Act, regulatory agency standards, and policies and procedures. Functions as… more
- Advocate Aurora Health (Charlotte, NC)
- …for robust benefits packages and paid time off. The Kidney Dialysis Unit at CMC is an inpatient dialysis center. They provide dialysis for inpatients at Atrium ... at Atrium Health Mercy. Atrium Health Carolinas Medical Center ( CMC ) is the flagship hospital of Atrium Health, which...direct provision of patient care and for assisting the manager with daily operations to include but not limited… more
- BioSpace (Armonk, NY)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). A ... Job Details 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
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). Minimum of 5 years' experience as a… more
- Aligos Therapeutics (South San Francisco, CA)
- …the opportunities waiting for you at Aligos. Position Summary : The Clinical Trial Manager will report directly to the Head of Clinical Operations and will be ... and final reconciliation of study documents including review of site regulatory documents/packages. Ensuring GCP compliance and inspection readiness are maintained… 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
- 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
