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Senior Associate Regulatory Affairs, Amgen, Thousand Oaks, CA (11/2/08)

JOB DESCRIPTION:
Amgen’s Regulatory Affairs & Safety organization has exciting full-time opportunities for graduating students, 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:

• Participate in Global Regulatory Team to support development and execution of regulatory strategy
• Review Global Regulatory Plan and provide input to operational deliverables
• Ensure compliance of submissions to regulatory agencies
• Collaborate with CROs / partners to support site initiation
• 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 and appropriately archive all regulatory documents
• Actively support regulatory compliance
• 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

BASIC QUALIFICATIONS

• BA/BS degree in life sciences, business or engineering field
• In final year of completing MBS degree with emphasis in Clinical Regulatory Affairs or MS in Regulatory Science
• 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

APPLICATION INSTRUCTIONS

For consideration go to www.amgen.com à click on the Careers link à Job Search à Search Jobs à in the Search for field enter NB50361441 à complete the application process.

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

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