Senior Director, Regulatory Affairs REMS Program

Cytokinetics · South San Francisco, CA +1 more

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RegulatoryFull-time$264k–$308kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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Date posted4 days ago

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