- 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
- 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
- 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
- Charles River Laboratories (Rockville, MD)
- …build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. Responsible for ... mapping resource across projects. In this role, the Senior CMC Project Manager is the key interface...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… 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
- Lilly (Lebanon, IN)
- …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
- 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
- Bausch Health (Bridgewater, NJ)
- …+ Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory ... and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ regulatory … 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
- Haleon (Richmond, VA)
- …uniquely ours. Care to join us. It isn't a question. The **QA Manager ** leads Quality and Compliance activities for assigned product projects during the development ... point of contact for quality aspects related to development, analytical, regulatory , medical/safety, technology and manufacturing + Quality liaison in development… more
- Merck (West Point, PA)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- CVS Health (Austin, TX)
- …with heart, each and every day. **Position Summary:** Care Management Coordinators ( CMC ) drive and support care management and care coordination activities across ... of care (assessing, planning, implementing, coordinating, monitoring, and evaluating). The CMC utilizes critical thinking and judgment to collaborate and inform the… more
- Merck (Rahway, NJ)
- …within 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
