Open Position of US Regulatory Professional at Amgen
Company name: Amgen
Role: US Regulatory Professional
Contact: Shirin Pillay at
This is a contract position (usually 11 months) within the Regulatory Affairs department of Amgen.
Basic Qualifications
• Strong communication, presentation skills and team player skills
• Proficient in Microsoft Office
• Biotechnology, pharmaceutical, medical device and/or healthcare experience is valued but
not required Amgen Inc. retains the discretion to add or change the duties of the position at
any time. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the
workplace
Job Summary
Amgen’s Regulatory Affairs & Safety organization has exciting contract opportunity supporting
one of Amgen’s therapeutic area teams (Oncology, Hematology, Nephrology, Inflammation,
General Medicine or Bone). The objectives of these teams are to facilitate product development
and lifecycle management to achieve desired regional labeling by developing and executing
regulatory strategies through effective regulatory agency interactions.
Key responsibilities include:
1. Participate in Global Regulatory Team to support development and execution of regulatory strategy
2. Review Global Regulatory Plan and provide input to operational deliverables
3. Ensure compliance of submissions to regulatory agencies
4. Collaborate with CROs / partners to support site initiation
5. Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
6. Coordinate collection of functional documents in support of regulatory applications (e.g. Site Initiation Packages, financial disclosure)
7. Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Representative
8. Create and maintain product regulatory history documents and appropriately archive all regulatory documents
9. Actively support regulatory compliance
10. Coordinate QC of regulatory documentation (e.g. briefing packages)
11. Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
12. Prepare regulatory packages and cross-reference letters to support investigator initiated studies
13. Approve drug shipment for Amgen and Investigator Initiated Studies
14. Complete regulatory forms to support agency communications (E.G. Eudract, FDA form 1571)
15. Standards Development and Maintenance
16. Support process improvement initiatives, standards development, and metrics
17. Assist in template development and maintenance
