Senior Director, Regulatory Affairs REMS Program

Cytokinetics, Inc.; United States; On-site; USD 263,880 - 307,860; Full time

Job summary

Cytokinetics, Inc. is seeking a Regulatory Lead to manage REMS-related interactions with the FDA. The successful candidate will possess over 10 years of experience in the pharmaceutical or biotech industry, specifically in REMS operations and strategy. Responsibilities include leading REMS strategies, overseeing regulatory compliance, and preparing submissions.

A Bachelor’s degree in a scientific discipline is required, with advanced degrees preferred. The role offers a salary range of $263,880 - $307,860 per year.

Qualifications

• 10+ years of relevant experience in the pharmaceutical/biotech industry.
• Strong expertise in REMS operations, strategy, and compliance.
• Excellent knowledge of regulatory requirements applicable to REMS.

Responsibilities

• Serve as regulatory lead for all REMS-related interactions.
• Lead development of REMS strategies.
• Prepare and lead REMS discussions for FDA meetings.
• Manage REMS filings, assessments, and queries.

Skills

REMS operations

Regulatory compliance

Cross-functional collaboration

Leadership and mentoring

Communication skills

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MD, PharmD, or PhD)

Job description

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 that align with benefit–risk profile, labeling, post marketing commitments, and lifecycle plans.
• Drive 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.
• 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.
• 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.
• Manage and mentor employees, consultants/contractors, and/or interns in Regulatory Affairs.
• Mentor department personnel and optimize employee performance by developing employees and promoting career growth.

Qualifications

• 10+ years of relevant experience in the pharmaceutical/biotech industry, with strong expertise in REMS operations, strategy and compliance.
• Bachelor’s degree 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.

Compensation

Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $263,880 - $307,860 per year.

Cytokinetics is an Equal Opportunity Employer.