Senior Director, Regulatory Affairs REMS Program

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 aligned 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 preparation and timely submission of REMS filings, REMS assessments, and responses to queries.
- Oversee implementation and evaluation of REMS in alignment with program strategy.
- Monitor evolving FDA REMS guidance and assess regulatory impact.
- Provide regulatory guidance to Commercial, Market Access, and Patient Services to ensure compliant execution.
- Identify regulatory risk gaps and develop mitigation solutions.
- Develop and maintain internal regulatory processes, templates, and best practices.

REMS Design & Governance:
- Own global oversight of REMS design, including ETASU, communication plans, implementation systems, and assessment methodologies.
- Serve on the REMS governance committee; lead compliance and assessment/reporting functions in partnership with operations.
- 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, audit support, and CAPA management.
- Support regulatory inspections and FDA audits related to REMS.

Management:
- May supervise employees, consultants/contractors, and/or interns in Regulatory Affairs.
- Mentor personnel and promote career growth.

Qualifications:
- 10+ years of relevant pharmaceutical/biotech experience with strong REMS operations, strategy, and compliance expertise.
- Bachelor’s degree required (preferably scientific); advanced degree (MD, PharmD, or PhD) a plus.
- Strong knowledge of regulatory requirements applicable to REMS, including GXP.
- Direct experience leading or negotiating REMS with FDA strongly preferred.
- Ability to collaborate across teams and partners.
- Excellent oral/written communication; strong organizational/time management; attention to detail; ability to independently drive deliverables.
- Ability to manage multiple priorities in a fast-paced environment.