- 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 (Washington, DC)
- … Affairs CMC Senior Manager **Live** **What you will do** The CMC Regulatory Senior Manager is responsible for execution and/ or coordination of ... strategy for an assigned set of commercial products. The CMC Regulatory Senior Manager is...degree and 5 years of directly related experience OR Associate 's degree and10 years of directly related experience OR… 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
- Amgen (Washington, DC)
- … Lead** **Live** **What you will do** Let's do this. Let's change the world.The Regulatory Affairs Manager CMC Contributes to product teams and acts as ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional ...Include: + Generate and execute of global and country-specific regulatory strategies + Provide CMC regulatory… more
- Actalent (Morristown, NJ)
- …Working knowledge of US FDA (OGD/CDER) e-submission requirements. + Experience with CMC regulatory requirements. Additional Skills & Qualifications + Experience ... Description We are seeking a highly skilled and motivated Regulatory Affairs Associate with extensive experience in...$90000.00 - $115000.00/yr. Hybrid work environment- good team good manager Workplace Type This is a hybrid position in… 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