Serve as regulatory lead and FDA point of contact for all REMS-related interactions, including original REMS submissions, assessments, modifications, and revisions
Lead development of REMS strategies that align with benefit-risk profile, labeling, post marketing commitments, and lifecycle plans. Drives cross-functional alignment and decision-making.
Prepare and lead REMS discussions for FDA meetings (Type A/B/C, Advisory Committees, inspections)
Manage all aspects of preparation and timely submission of REMS filings, REMS assessments, and responses to queries
Oversee implementation and evaluation of REMS in alignment with the broader program strategy
Monitor evolving FDA REMS guidance and proactively assess regulatory impact
Provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution.
Identify gaps that may pose regulatory risks and identify related solutions and mitigation plans
Develop and maintain internal regulatory processes, templates, and best practices
REMS Design & Governance
Own global oversight of REMS design, including Elements to Assure Safe Use (ETASU), communication plans, implementation systems, and assessment methodologies
Act as a key member of the REMS governance committee, leading compliance and assessment/reporting functions and partnering with operations to ensure end‑to‑end program oversight and regulatory compliance.
Ensure REMS requirements are clearly translated into operational execution plans.
Oversight & Compliance
Review and approve REMS related documentation, assessments, training materials, and vendor deliverables.
Oversee REMS metrics, compliance trends, and effectiveness assessments from a regulatory perspective.
Align with Quality to ensure inspection readiness, audit support, and CAPA management.
Support regulatory inspections and FDA audits related to REMS.
Management
May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs
Mentors department personnel and optimizes employee performance by developing employees and promoting career growth.
Requirements
10+ years of relevant experience in the pharmaceutical/biotech industry, with strong expertise in REMS operations, strategy and compliance
Bachelor's degree is required, preferably in a scientific discipline; advanced degree (MD, PharmD, or PhD) is a plus
Excellent working knowledge of regulatory requirements and environment applicable to REMS, including an understanding of GXP
Direct experience leading or negotiating REMS with FDA strongly preferred
Ability to work effectively across teams, functions and with outside partners
Excellent oral and written communication skills
Excellent organizational and time management skills, attention to detail, and ability to independently drive deliverables to completion
Ability to work effectively in a fast-paced environment while managing multiple priorities
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Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $263,880 - $307,860 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
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Benefits
Vision insuranceEquity / stock options
Additional Information
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Reporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution related to Risk Evaluation and Mitigation Strategy (REMS) and providing regulatory compliance oversight for REMS.
Cytokinetics · South San Francisco, CA