Senior Director, Regulatory Affairs REMS Program
Cytokinetics
August 07, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
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.
Responsibilities
- 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 aligned with benefit–risk profile, labeling, post marketing commitments, and lifecycle plans; drive cross-functional alignment
- Prepare and lead REMS discussions for FDA meetings (Type A/B/C, Advisory Committees, inspections)
- Manage preparation and timely submission of REMS filings, REMS assessments, and responses to queries
- Oversee implementation and evaluation of REMS; monitor evolving FDA REMS guidance
- Provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution
- Identify regulatory risks/gaps and develop mitigation plans; develop and maintain internal regulatory processes/templates/best practices
- Own global oversight of REMS design (ETASU), communication plans, implementation systems, and assessment methodologies; lead compliance/assessment/reporting within REMS governance
- Review/approve REMS documentation, assessments, training materials, and vendor deliverables; oversee REMS metrics and effectiveness assessments; align with Quality for inspection readiness and CAPA
- Support regulatory inspections and FDA audits related to REMS
- May supervise and mentor Regulatory Affairs personnel (employees, consultants/contractors, interns)
Qualifications
- 10+ years in pharmaceutical/biotech with strong REMS operations, strategy, and compliance expertise
- Bachelor’s degree required (preferably scientific); advanced degree (MD, PharmD, PhD) preferred
- Strong knowledge of regulatory requirements applicable to REMS, including GXP
- Direct experience leading/negotiating REMS with FDA strongly preferred
- Ability to collaborate across teams and partners; excellent oral/written communication
- Strong organization/time management, attention to detail, and ability to drive deliverables to completion in a fast-paced environment
Responsibilities
- 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 aligned with benefit–risk profile, labeling, post marketing commitments, and lifecycle plans; drive cross-functional alignment
- Prepare and lead REMS discussions for FDA meetings (Type A/B/C, Advisory Committees, inspections)
- Manage preparation and timely submission of REMS filings, REMS assessments, and responses to queries
- Oversee implementation and evaluation of REMS; monitor evolving FDA REMS guidance
- Provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution
- Identify regulatory risks/gaps and develop mitigation plans; develop and maintain internal regulatory processes/templates/best practices
- Own global oversight of REMS design (ETASU), communication plans, implementation systems, and assessment methodologies; lead compliance/assessment/reporting within REMS governance
- Review/approve REMS documentation, assessments, training materials, and vendor deliverables; oversee REMS metrics and effectiveness assessments; align with Quality for inspection readiness and CAPA
- Support regulatory inspections and FDA audits related to REMS
- May supervise and mentor Regulatory Affairs personnel (employees, consultants/contractors, interns)
Qualifications
- 10+ years in pharmaceutical/biotech with strong REMS operations, strategy, and compliance expertise
- Bachelor’s degree required (preferably scientific); advanced degree (MD, PharmD, PhD) preferred
- Strong knowledge of regulatory requirements applicable to REMS, including GXP
- Direct experience leading/negotiating REMS with FDA strongly preferred
- Ability to collaborate across teams and partners; excellent oral/written communication
- Strong organization/time management, attention to detail, and ability to drive deliverables to completion in a fast-paced environment