Senior Associate US Regulatory Affairs

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Senior Associate US Regulatory Affairs

PREFERRED QUALIFICATIONS:

• Strong communication skills – oral and written
• Organizational skills
• Regulated industry, science or clinical practice experience

Let’s do this. Let’s change the world. In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

• Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications (BLAs) and New Drug Applications (NDAs); advisory committee meeting preparations)
• Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL
• Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
• Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
• Actively support regulatory compliance and ensure compliance of submissions to the US FDA
• Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label.
• Coordinate collection of functional documents in support of regulatory applications
• Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes)
• Assist the USRL in managing the process for responding to FDA questions
• Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports)
• Prepare regulatory packages and cross-reference letters to support investigator initiated studies
• Complete regulatory forms to support agency communications (e.g. FDA form 1571)
• Support process improvement initiatives, standards development, and metrics
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Support the development and execution of GRT goals