Senior Associate Regulatory Affairs, Nb50249230 - Thousand Oaks, Ca
Amgen Inc (Ventura County, California)

This job posting has expired.

You may wish to try a search for Senior Associate Regulatory Affairs, NB50249230 - Thousand Oaks, CA

Or visit the FlipDog home page
 

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. We are seeking talented individuals to help bring our products to those in need. This is an opportunity for a Sr. Associate position on a Therapeutic Area team within Amgen’s Regulatory Affairs department. The Therapeutic Area team facilitates product development and global registration to achieve the desired regional labeling by developing and executing regulatory strategies and effective regulatory agency interactions. Key responsibilities include: - Represent GRAAS - Review GRP and provide input to operational deliverables - Ensure compliance with submissions to regulatory agencies - Assemble and provide timely input to GRT, consistent with GRT strategy - Respond to specific requests from- and communicate relevant issues to GRT - Collaborate with CRO’s / partners to support site initiation - Develop Regulatory Position with teams - Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations) - Coordinate collection of functional documents in support of regulatory applications (e.g. Site Initiation Packages, financial disclosure) - Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Representative - Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications - Actively support regulatory compliance - Participate in GRT to support execution of regulatory strategy - Support the development and execution of GRT goals - Coordinate QC of regulatory documentation (e.g. briefing packages) - Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) - Prepare regulatory packages and cross-reference letters to support investigator initiated studies - Approve drug shipment for Amgen and Investigator Initiated Studies - Complete regulatory forms to support agency communications (E.G. Eudract, FDA form 1571) - Standards Development and Maintenance - Support process improvement initiatives, standards development, and metrics - Assist in template development and maintenance - Management Responsibilities - Assist with on-boarding of new product coordinators - Bachelors degree and a minimum of 3 years biotech/pharmaceutical work experience in a regulatory environment Preferred Qualifications: - Masters degree plus 0 - 2 years biotech/pharmaceutical experience - Doctoral degree