Sr. Director, Regulatory Affairs

McKesson•Richmond, VA

1d•$157,500 - $262,500•Hybrid

About The Position

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.

Requirements

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).
Deep working knowledge of FDA, DEA, and global regulatory frameworks
Strong understanding of quality systems and regulatory compliance principles
Ability to lead in a highly matrixed enterprise environment
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.
Bachelor’s degree required

Responsibilities

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.).
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.
Create programs to monitor the evolving regulatory landscape and assess potential impacts to distribution operations, MMS brands and product servicing.
Develop processes ensuring timely implementation of regulatory changes.
Monitor regulatory changes to ensure compliance and lead company-wide training on regulatory requirements.
Engage in industry affiliations to advocate for McKesson interest.
Builds and oversees risk‑mitigation program requirements (e.g., REMS / iPledge).
Ensure timely registration of Create regulatory program for 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.