Senior Director, Regulatory Affairs REMS Program
Cytokinetics
June 25, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Responsibilities
Strategic Leadership
- 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, assessments, and responses to queries.
- Oversee REMS implementation and evaluation; monitor evolving FDA REMS guidance and assess regulatory impact.
- Provide regulatory guidance to Commercial, Market Access, and Patient Services for compliant execution.
- Identify regulatory-risk gaps and develop mitigation plans; develop and maintain internal regulatory processes, templates, and best practices.
REMS Design & Governance
- Own global oversight of REMS design (ETASU), communication plans, implementation systems, and assessment methodologies.
- Lead compliance and assessment/reporting functions as part of the REMS governance committee; ensure end-to-end oversight.
- Translate REMS requirements into operational execution plans.
Oversight & Compliance
- Review/approve REMS documentation, assessments, training materials, and vendor deliverables.
- Oversee REMS metrics, compliance trends, and effectiveness assessments; align with Quality for inspection readiness, audits, and CAPA.
- Support regulatory inspections and FDA audits related to REMS.
Management
- May supervise Regulatory Affairs employees/contractors/interns; mentor and support career growth.
Qualifications
- 10+ years in pharmaceutical/biotech with REMS operations, strategy, and compliance expertise.
- Bachelor’s degree required (preferably scientific); MD/PharmD/PhD preferred/plus.
- Strong knowledge of REMS regulatory requirements and GXP.
- Direct experience leading/negotiating REMS with FDA strongly preferred.
- Ability to work cross-functionally and with partners; excellent oral/written communication.
- Strong organization/time management, attention to detail, independent delivery, and ability to manage multiple priorities.
Pay Range (U.S.)
- $263,880 - $307,860 per year.
Strategic Leadership
- 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, assessments, and responses to queries.
- Oversee REMS implementation and evaluation; monitor evolving FDA REMS guidance and assess regulatory impact.
- Provide regulatory guidance to Commercial, Market Access, and Patient Services for compliant execution.
- Identify regulatory-risk gaps and develop mitigation plans; develop and maintain internal regulatory processes, templates, and best practices.
REMS Design & Governance
- Own global oversight of REMS design (ETASU), communication plans, implementation systems, and assessment methodologies.
- Lead compliance and assessment/reporting functions as part of the REMS governance committee; ensure end-to-end oversight.
- Translate REMS requirements into operational execution plans.
Oversight & Compliance
- Review/approve REMS documentation, assessments, training materials, and vendor deliverables.
- Oversee REMS metrics, compliance trends, and effectiveness assessments; align with Quality for inspection readiness, audits, and CAPA.
- Support regulatory inspections and FDA audits related to REMS.
Management
- May supervise Regulatory Affairs employees/contractors/interns; mentor and support career growth.
Qualifications
- 10+ years in pharmaceutical/biotech with REMS operations, strategy, and compliance expertise.
- Bachelor’s degree required (preferably scientific); MD/PharmD/PhD preferred/plus.
- Strong knowledge of REMS regulatory requirements and GXP.
- Direct experience leading/negotiating REMS with FDA strongly preferred.
- Ability to work cross-functionally and with partners; excellent oral/written communication.
- Strong organization/time management, attention to detail, independent delivery, and ability to manage multiple priorities.
Pay Range (U.S.)
- $263,880 - $307,860 per year.