Senior Director, Regulatory Affairs REMS Program

Role: Senior Director, Regulatory Affairs, REMS Program, leading regulatory strategy and compliance oversight for REMS activities within a cardiovascular biopharmaceutical company. Responsibilities: serve as FDA point of contact for REMS interactions, develop and execute REMS strategies aligned with product benefit-risk profiles, lead FDA discussions, manage REMS filings and assessments, oversee global REMS design (including Elements to Assure Safe Use), and ensure compliance through documentation review, metrics analysis, and inspection support. Qualifications: 10+ years of experience in pharma/biotech regulatory affairs with specific expertise in REMS operations, strategy, and compliance; Bachelor's degree required, advanced degrees (MD, PharmD, PhD) preferred; strong knowledge of GxP and FDA regulations; experience with direct FDA negotiations a plus; excellent communication, organizational, and cross-functional collaboration skills. HighValue: focus on REMS, regulatory strategy, FDA interactions, global oversight, compliance, and risk mitigation in a specialty cardiovascular setting. WorkSetup: not specified; senior leadership role involving cross-functional engagement.