- The Boeing Company (Seal Beach, CA)
- …Find your future with us. **The Boeing Company** is looking for an ** Associate Quality Systems Specialist** **( Regulatory Regulations)** to join our team onsite ... or Seattle, WA.** As a member of the Designated Regulatory Office (DRO) you will support FAA Certification activities...Bachelor's Degree or higher + Experience in specialty materials ** Drug Free Workplace:** Boeing is a Drug … more
- GRAIL (Olympia, WA)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... + Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III...and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals. **Job Description** The Assoc. Director, IT Regulatory , Clinical and Enterprise Systems is an integral part of bringing ... RayzeBio's innovative drug products to patients in need. In this role,...processes to achieve commercialization objectives across the Clinical Operations, Regulatory , Planning and Enterprise Systems. The role will ensure… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director, Drug Product Manufacturing Science & Technology, you will be ... Takeda's global subject matter expert for small-molecule drug product and packaging. You will lead how tablets,...drug product and packaging processes in line with regulatory and Takeda standards. + Act as part of… more
- Novo Nordisk (Boulder, CO)
- …the best of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical ... in a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage their own projects. Relationships This position reports to the… more
- Lilly (Lebanon, IN)
- …and build a manufacturing supply chain from ground-up. The Manufacturing Associate will be responsible for performing routine manufacturing activities across GMP ... at the Lebanon Advanced Therapies, LP2 site. Initially, the Manufacturing Associate will be responsible for supporting execution of equipment qualification,… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. The Associate Vice President, Drug Products External Manufacturing is a critical leadership ... role accountable for Lilly's global external manufacturing network across drug products (parenteral, oral solids), combination devices, and packaging. This executive… more
- Lilly (Indianapolis, IN)
- …+ Ensure process definition of critical parameters are in alignment with regulatory submission. + Ensure that each of the department and external partner ... operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight....and grow the technical ability to be consistent with Drug Product External Manufacturing (DPEM) business needs for the… more