The RA CMC Group is responsible for generation of the global regulatory strategy and providing feedback to the team for plans and execution of the strategy. Facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
Job Summary: Develop and implement regulatory strategies to support both new and existing combination products and innovative delivery devices.
Key Activities: • Provide strategic expertise regarding regulatory requirements for drug delivery device related projects • Interface with Regulatory Authorities as appropriate • Work in conjunction with Global RA product leads and Regional RA representatives • Serve as Regulatory Affairs representative on Cross Functional Teams regarding drug delivery devices • Support Regulatory Filings and provide team guidance regarding: o US 510(k) filings o CE Mark requirements o Device quality management system requirements o ISO requirements o Clinical requirements for drug delivery devices o Device registration maintenance including Registration renewals o Complaints and Recalls • Review and approve selected regulatory documents • Represent Regulatory Affairs to outside departments, product teams and regulatory agencies • Represent Amgen at external events (PhRMA, PDA, ISPE, BIO, etc.), as appropriate • Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts • Serve as the primary resource within the RA-CMC team to support drug/device combination products or other drug delivery device projects
Basic Qualifications • Doctorate degree and 2+ years of directly related experience OR • Master's degree and 6+ years of directly related experience OR • Bachelor's degree and 8+ years of directly related experience OR • Associate's degree and 10+ years of directly related experience OR • High school diploma / GED and 12+ years of directly related experience
Preferred Qualifications - Degree in Life Sciences, Engineering or related field - 7+ years of related experience in the pharmaceutical/biotechnology or medical device industry - 5+ years experience in Regulatory Affairs - Regulatory experience with Drug/Device combination products or drug delivery device product filings a requirement - Ability to work within a matrix team environment - Able to operate in a fast paced, dynamic environment - Able to manage and execute activities to meet agreed upon timelines - Strong oral and written communication skills - Strong negotiating and leadership skills - International experience - preferred
