Sr Regulatory Affairs (REMS) Specialist

McKesson•Richmond, VA

1d•Hybrid

About The Position

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you. Our Quality Assurance team is growing! We are excited to welcome a Sr. Regulatory Affairs (REMS) Specialist who will play a pivotal role in the expansion of our REMS portfolio. With our REMS business projected to grow significantly over the next year , this is a high‑impact opportunity to take ownership of critical REMS programs, influence strategic decisions, and help build the infrastructure that will support our rapid expansion. If you are passionate about patient safety, regulatory excellence, and shaping the future of REMS operations, we want to meet you. Position Summary: The Sr. Regulatory Affairs Specialist is a senior‑level role responsible for full ownership and lifecycle management of FDA‑mandated Risk Evaluation and Mitigation Strategy (REMS) programs. This is not a general Regulatory Affairs position— direct, hands‑on REMS experience is essential . This specialist serves as the enterprise REMS subject‑matter expert and the primary liaison between our Medical‑Surgical business and the FDA. The role partners with Quality, Category Management, Commercial, Legal, and external REMS sponsors to ensure programs are designed, implemented, monitored, and maintained in strict alignment with FDA expectations. As REMS volume continues to scale, the individual in this role will also support broader regulatory responsibilities such as SDS reviews and other regulatory activities . Hybrid Expectations: The majority of time in this role will be spent working remotely from home. However, team meetings or other Medical Surgical events may make it necessary for employees to be present in the office each month.

Requirements

7+ years of relevant professional experience
Direct, hands‑on experience managing FDA REMS programs

Nice To Haves

Advanced degree (PharmD, MS, or related field)
Experience supporting REMS programs during FDA inspections or audits
Familiarity with regulated training systems, SOP management platforms, and compliance tools
Experience in wholesale distribution, specialty distribution, or pharmacy environments
Strong regulatory judgment and risk‑based decision‑making
Proven ability to influence cross‑functional teams without direct authority
Exceptional communication, documentation, and organizational skills
Ability to thrive in a fast‑paced, rapidly evolving regulatory environment

Responsibilities

REMS Program Ownership & Oversight Serve as the enterprise owner for all assigned REMS programs, ensuring full compliance with FDA requirements.
Lead the design, implementation, and lifecycle management of REMS programs.
Manage the REMS audit process , including documentation preparation, submission, responses, and closure.
Ensure all REMS Quality Management System requirements are followed with strong documentation controls.
Partner with commercial and sales teams as they identify new REMS product opportunities; provide all necessary regulatory requirements and feasibility insights.
Act as the primary liaison between the Medical‑Surgical business and the FDA for REMS activities.
Investigate potential non‑compliance; develop, approve, and submit corrective and preventive actions (CAPAs).
Oversee REMS‑related training for internal teams, partners, and customers.
Regulatory Compliance & Governance Interpret FDA REMS requirements and translate them into compliant operational processes and controls.
Maintain SOPs, work instructions, training materials, and supporting documents in alignment with Quality System standards.
Support inspection readiness efforts and represent REMS program design and compliance during regulatory inspections.
Monitoring, Reporting & Continuous Improvement Develop metrics and dashboards for REMS compliance performance; track deviations and implement CAPAs.
Prepare and submit REMS assessments, reports, and communications to FDA or REMS sponsors.
Evaluate new or changing REMS requirements and assess operational impact.
Develop processes for monitoring regulatory changes and communicating updates to stakeholders.
Broader Regulatory Support Provide SDS and other regulatory support during early stages of REMS business expansion.
Assist the Quality and Regulatory teams with additional compliance needs as required during growth phases.