Sr. Director, Regulatory Affairs

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.
• Regulatory Intelligence & Sensing
• 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.
• 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 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.

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
• Education:
• Bachelor's degree required
• About Medical-Surgical

Benefits

Additional Information

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. Sr. Director - Regulatory Affairs Location : Richmond, VA, USA - 9954 Mayland Drive Hybrid - must be able to attend meetings in the office 2-3 times/week This position comes with competitive pay, a full benefit package that includes 401K, stock, PTO, and other perks. There is also a 25% incentive program. Position Summary: 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.

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