Reporting to the Executive Director, Regulatory Affairs, the Senior Director, RegulatoryAffairs, 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: Strategic Leadership 3 Serve as regulatory lead and FDA point of contact for all REMS-related interactions, including original REMS submissions, assessments, modifications, and revisions 3 Lead development of REMS strategies that align with benefit 6risk profile, labeling, post marketing commitments, and lifecycle plans. Drives cross-functional alignment and decision-making. 3 Prepare and lead REMS discussions for FDA meetings (Type A/B/C, Advisory Committees, inspections) 3 Manage all aspects of preparation and timely submission of REMS filings, REMS assessments, and responses to queries 3 Oversee implementation and evaluation of REMS in alignment with the broader program strategy 3 Monitor evolving FDA REMS guidance and proactively assess regulatory impact 3 Provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution. 3 Identify gaps that may pose regulatory risks and identify related solutions and mitigation plans 3 Develop and maintain internal regulatory processes, templates, and best practices REMS Design & Governance 3 Own global oversight of REMS design, including Elements to Assure Safe Use (ETASU), communication plans, implementation systems, and assessment methodologies 3 Act as a key member of the REMS governance committee, leading compliance and assessment/reporting functions and partnering with operations to ensure end
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9end program oversight and regulatory compliance. 3 Ensure REMS requirements are clearly translated into operational execution plans. Oversight & Compliance 3 Review and approve REMS related documentation, assessments, training materials, and vendor deliverables. 3 Oversee REMS metrics, compliance trends, and effectiveness assessments from a regulatory perspective. 3 Align with Quality to ensure inspection readiness, audit support, and CAPA management. 3 Support regulatory inspections and FDA audits related to REMS. Management 3 May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs 3 Mentors department personnel and optimizes employee performance by developing employees and promoting career growth. Qualifications: 3 10+ years of relevant experience in the pharmaceutical/biotech industry, with strong expertise in REMS operations, strategy and compliance 3 Bachelor 27s degree is required, preferably in a scientific discipline; advanced degree (MD, PharmD, or PhD) is a plus 3 Excellent working knowledge of regulatory requirements and environment applicable to REMS, including an understanding of GXP 3 Direct experience leading or negotiating REMS with FDA strongly preferred 3 Ability to work effectively across teams, functions and with outside partners 3 Excellent oral and written communication skills 3 Excellent organizational and time management skills, attention to detail, and ability to independently drive deliverables to completion 3 Ability to work effectively in a fast-paced environment while managing multiple priorities #LI-HYBRID 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. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.