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Senior Associate Regulatory Affairs
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Full-time
- The International Regulatory Lead (Sr. Associate) is assigned to one or more Amgen products and may support an IRL or lead a program under the supervision of an experienced regulatory lead.
- Provides regulatory direction/expertise on regulatory mechanisms, regulatory risks and implications and requirements to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan) (if leading a program).
- Assists the International Regulatory Lead to support the regulatory activities and prepare supportive documentation (e.g. Clinical trial submissions, Marketing applications and lifecycle management filings) in compliance with global filing plans and local regulatory requirements.
- Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance and obtain relevant histories, precedence and other information relating to Amgen products.
- Understanding of drug development.
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