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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 highimpact opportunity to take ownership of critical REMS programs influence strategic decisions and help build the infrastructure that will support our rapid expansion.

This is not a general Regulatory Affairs positiondirect REMS experience is needed for consideration. Because this role serves as the enterprise REMS subjectmatter expert and primary liaison with the FDA candidates must have previous handson experience managing REMS programs.

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 seniorlevel role responsible for full ownership and lifecycle management of FDAmandated Risk Evaluation and Mitigation Strategy (REMS) programs. This is not a general Regulatory Affairs positiondirect handson REMS experience is essential. This specialist serves as the enterprise REMS subjectmatter expert and the primary liaison between our MedicalSurgical 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.

Key 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 MedicalSurgical business and the FDA for REMS activities.

• Investigate potential noncompliance; develop approve and submit corrective and preventive actions (CAPAs).

• Oversee REMSrelated 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.

Minimum Requirements:

• 7 years of relevant professional experience

Critical Preferred Skills:

• Direct handson experience managing FDA REMS programs

• 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 riskbased decisionmaking

• Proven ability to influence crossfunctional teams without direct authority

• Exceptional communication documentation and organizational skills

• Ability to thrive in a fastpaced rapidly evolving regulatory environment

Travel Requirements:

• 1015% travel expected

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors including performance experience and skills equity regular job market evaluations and geographical markets. The pay range shown below is aligned with McKessons pay philosophy and pay will always be compliant with any applicable regulations. In addition to base pay other compensation such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson pleaseclick here.

Our Base Pay Range for this position

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