- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid ... CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and… 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
- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible ... for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory ... are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day might include the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… 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
- Teva Pharmaceuticals (West Chester, PA)
- Manager , Regulatory Affairs Date: Jun 3, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 61795 **Who we ... spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester,...Authority Applications (directly or indirectly) + Authoring and Reviewing CMC content for use in Health Authority Applications +… more
- Fresenius Medical Center (Knoxville, TN)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders **Job 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
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …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 (Miami, FL)
- …of health Recruiting for this role ends 6/30/2025 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)
- …aspects of product development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is ... and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned… 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
- Integra LifeSciences (Plainsboro, NJ)
- …to advance patient outcomes and set new standards of care. The **EHS Manager ** provides the oversight and management of the Collagen Manufacturing Center ( CMC ... EH&S services to the office and manufacturing personnel within the Integra CMC facility. + Establishes and monitors standards, policies, and procedures for… more
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