Senior Director, Regulatory Affairs REMS Program

Cytokinetics; South San Francisco (CA); On-site; USD 263,880 - 307,860; Full time

Job summary

Cytokinetics is seeking a Senior Director for Regulatory Affairs in South San Francisco. This role involves leading regulatory strategies related to Risk Evaluation and Mitigation Strategies (REMS), ensuring compliance, and managing cross-functional teams.

The ideal candidate has over 10 years of experience in the pharmaceutical sector, with a strong background in REMS operations and strategy. The position offers a competitive salary range of $263,880 to $307,860 per year.

Qualifications

• 10+ years of relevant experience in the pharmaceutical/biotech industry.
• Strong expertise in REMS operations, strategy, and compliance.
• Understanding of GXP regulations.

Responsibilities

• Lead regulatory strategy and FDA interactions for REMS.
• Oversee REMS filings, assessments, and compliance activities.
• Manage cross-functional alignment in REMS discussions.

Skills

Regulatory strategy

REMS operations

Compliance oversight

Cross-functional team leadership

Excellent communication

Education

Bachelor’s degree in scientific discipline

Advanced degree (MD, PharmD, or PhD)

Job description

## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime type: Full timeposted on: Posted 2 Days Agojob requisition id: R482Cytokinetics 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.# **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 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.# **Qualifications:*** 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 #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.