- Lilly (Philadelphia, PA)
- …make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... 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
- Amgen (New Albany, OH)
- … Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for ... experience OR + Bachelor's degree and 5 years of Regulatory & Compliance experience OR + Associate 's...(QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and ... + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory … more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie is seeking an Associate Project Manager to drive the execution and oversight of ... to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership.… 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
- Merck (Rahway, NJ)
- …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
- Rhythm Pharmaceuticals (Boston, MA)
- …quality culture across the board. The Manager QA will report to the Associate Director, QA CMC , based in The United States, while supporting and liaising ... our tenacity to overcome barriers, together. Opportunity Overview Rhythm is looking for a Manager Quality Assurance (QA) to play a key role in ensuring quality and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Pivotal & Commercial Formulation and Process Development** , as an **Sr.** ** Associate Scientist** . The successful candidate will contribute to the development of ... documentation practices. + Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Novo Nordisk (Boulder, CO)
- …QC, Internal Chemical Development, Drug Product Manufacturing, Program Management, CMC Regulatory , Manufacturing Operations, and Contract Manufacturing ... Nordisk internal manufacturing sites. Relationships This position reports to the Associate Director of Drug Substance Development and Manufacturing. This position… more
- Rochester Regional Health (Rochester, NY)
- …ICD-10-CM and/or CPT codes for billing, internal and external reporting, research, and regulatory compliance. Under the direction of the HIM Coding Manager , ... to assigned charts in order to optimize reimbursement and/ or resolve regulatory edits. Resolve error reports associated with billing process, identify and report… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ The successful candidate will form strong partnerships with the CMC organisation, ensuring the appropriate development, manufacturing, and testing processes of ... assets are of the highest quality and compliant with regulatory requirements. + The GPL will build team effectiveness...budgets and timelines in close collaboration with the Project Manager (PM) assigned from the PMO. + The GPL… more
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