Senior Associate Regulatory Affairs

Role: Senior Associate in Regulatory Affairs supporting US regulatory submissions and agency interactions within Amgen's pipeline. Responsibilities: coordinate preparation, delivery, archiving of regulatory documentation (e.g., IND filings, amendments, reports); support global regulatory team and manage interactions with CROs; assist in maintaining regulatory information systems; prepare routine correspondence and participate in GRT activities. Requirements: Master’s degree or equivalent experience (minimum 2 years regulatory experience with Bachelor’s, or 6 years with Associate’s, or 8 years with high school diploma); strong communication skills, scientific understanding, ability to collaborate, organize, and prioritize. HighValue: US regulatory submissions, IND/CTA support, cross-functional collaboration, experience with global regulatory strategies, and compliance with GxP standards. WorkSetup: Not specified; based in the US with potential for hybrid or remote arrangements.