Regulatory Affairs Manager - Oncology and Regulatory Promotion

Role: Regulatory Affairs Manager specializing in Oncology and Regulatory Promotion, responsible for developing and communicating regulatory promotional strategies for Amgen's approved and pipeline oncology products and related disease states. Responsibilities include providing strategic direction for product and disease communication, ensuring compliance with FDA regulations and Amgen policies, and evaluating evidence for product claims. The role also involves mentoring promotional reviewers and identifying regulatory opportunities and challenges based on clinical data, competition, and evolving regulations. Qualifications: Doctorate or Master's degree with 2+ years of industry experience, or equivalent experience, with a preference for 2+ years in Oncology; strong understanding of US FDA advertising regulations, policies, and clinical data interpretation. High-Value: Oncology therapeutic area, pipeline and approved products, regulatory promotion, US FDA compliance, cross-functional collaboration with clinical, legal, and marketing teams. WorkSetup: not specified; likely office-based given the nature of the role.