Senior Director, Regulatory Affairs REMS Program

Cytokinetics seeks a Senior Director of Regulatory Affairs to lead REMS strategy, FDA interactions, and compliance oversight for a cardiovascular biopharmaceutical company. The role involves strategic leadership, REMS design governance, and cross-functional management in South San Francisco or Radnor, Pennsylvania.

Responsibilities

• Serve as regulatory lead and FDA point of contact for all REMS-related submissions, assessments, and modifications
• Lead development of REMS strategies aligned with benefit-risk profile, labeling, and lifecycle plans
• Manage preparation and timely submission of REMS filings, assessments, and FDA query responses
• Oversee REMS design, implementation, evaluation, and compliance metrics from regulatory perspective
• May supervise regulatory affairs employees, consultants, and interns; mentor team members

Requirements

• 10+ years pharmaceutical or biotech industry experience with REMS expertise
• Bachelor's degree required, preferably in scientific discipline; advanced degree (MD, PharmD, PhD) preferred
• Strong knowledge of regulatory requirements, GXP, and REMS compliance environment
• Direct experience leading or negotiating REMS submissions with FDA strongly preferred
• Excellent cross-functional collaboration, oral, and written communication abilities
• Strong organizational skills, attention to detail, and ability to manage multiple priorities independently

Compensation: $263,880 - $307,860 per year base pay