Sr. Director, Regulatory Affairs

About the role

The Sr. Director of Regulatory Affairs leads the development and execution of regulatory strategies to ensure compliance across the distribution and servicing of medical devices, pharmaceuticals, and food products. This role is accountable for aligning business operations with applicable regulatory requirements while enabling safe, compliant, and efficient product lifecycle management. The position serves as a senior advisor to leadership on regulatory risk, policy interpretation, and strategic decision-making, ensuring that regulatory obligations are proactively integrated into business initiatives.

Responsibilities

• Regulatory Compliance Execution: Develop and implement global regulatory strategies for product development, pre-approval, post-market compliance, distribution processes and product servicing. Establish standards to ensure reporting is accurate, complete and submitted in a timely manner to regulatory agencies. Drive consistent decision-making about patient safety issues, including potential recalls and product holds and quarantines. Serve as key contact for regulatory authorities (FDA, State regulatory agencies, etc.).
• Licensing and Registration: Oversee regulatory licensing and registration activities. Develop strategy for managing forthcoming regime of federal registration requirements applicable to drug wholesalers, 3PL, and controlled substances. Ensure accurate and timely applications are filed with regulatory agencies, and that updates on licensing requirements are conveyed to relevant stakeholders.
• Risk Evaluation & Mitigation (REMS / iPledge): Builds and oversees risk-mitigation program requirements (e.g., REMS / iPledge).
• Pre and Post Market Regulatory: Ensure timely registration of product submissions (e.g. 510ks, PMAs, NDA, etc.). Review and approve product labeling and promotional materials to ensure regulatory adherence. Performs additional responsibilities to support short- and long-term enterprise initiatives as assigned.

Qualifications

• Minimum Qualifications: Degree or equivalent experience. Typically requires 13+ years of professional experience and 6+ years of diversified leadership, planning, communication, organization, and people motivation skills (or equivalent experience).
• Skills and Qualifications: Deep working knowledge of FDA, DEA, and global regulatory frameworks. Strong understanding of quality systems and regulatory compliance principles. Excellent communication, organizational, and project management skills. Proven ability to influence and partner across business functions. Demonstrated ability to provide regulatory oversight and governance for the appropriate use of artificial intelligence and automation in regulated distribution environments. Working knowledge of AI-enabled regulatory intelligence, documentation, and compliance tools, including an understanding of associated risks related to data integrity, bias, validation, and explainability. Ability to translate AI-generated insights into defensible regulatory strategies, ensure compliance with FDA, DEA, and state regulatory expectations, and educate cross-functional partners on compliant AI use.

About Medical-Surgical

Medical-Surgical McKesson Medical-Surgical (MMS) is a subsidiary and publicly reported segment of the McKesson Corporation. MMS distributes medical-surgical supplies, pharmaceuticals, diagnostic equipment and supplies, along with other solutions and services to virtually every type of healthcare setting and provider outside of the traditional hospital. These markets – often referred to as Alternate Care or Non-Acute Care – include physician offices, surgery centers, long-term care providers, laboratories, home health and hospice agencies, health systems, government facilities and online marketplaces and retailers. Alternate Care markets are growing rapidly and MMS is proud to be a leader in this space. With a team of approximately 8,000 employees, a network of 15 distribution centers and approximately 900 delivery vehicles, we partner with more than 2,200 leading manufacturers and serve over 200,000 customer accounts across the U.S. Our catalog includes more than 280,000 SKUs of branded and private-label medical-surgical products – from bandages to specialty pharmaceuticals and COVID-19 tests.