Senior Director, Regulatory Affairs - REMS Program

4w4 weeks ago

Cytokinetics

Radnor, US · Full-time · $263,880 – $307,860

About this role

Cytokinetics, a specialty cardiovascular biopharmaceutical company with over 25 years of scientific innovation, is seeking a Senior Director of Regulatory Affairs to lead REMS program strategy and execution. This role reports to the Executive Director and provides regulatory compliance oversight for REMS.

The Senior Director serves as the primary FDA point of contact for all REMS interactions, including original submissions, assessments, and modifications. They lead development of REMS strategies that align with benefit-risk profiles and lifecycle plans, driving cross-functional alignment and decision-making. They also manage preparation and timely submission of REMS filings and responses to FDA queries.

This role oversees REMS governance, including design of Elements to Assure Safe Use, communication plans, and implementation systems. The director acts as a key member of the REMS governance committee, leading compliance and assessment functions while partnering with operations to ensure end-to-end program oversight. They provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution.

The position involves supervising and mentoring regulatory affairs staff, fostering career growth and optimizing team performance. It also requires staying abreast of evolving FDA REMS guidance and proactively assessing regulatory impact to mitigate risks. This is an opportunity to shape REMS strategy at a pioneering cardiovascular company.

Requirements

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 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.

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.
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.
Own global oversight of REMS design, including Elements to Assure Safe Use (ETASU), communication plans, implementation systems, and assessment methodologies.
Review and approve REMS related documentation, assessments, training materials, and vendor deliverables.
Supervise employees, consultants/contractors, and/or interns in Regulatory Affairs, mentoring department personnel and promoting career growth.