Sr. Director, Regulatory Affairs

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 Benefits - 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. Key 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. Build and oversee risk mitigation program requirements (e.g., REMS / iPledge). Ensure timely registration of regulatory program for product submissions (e.g., 510(k)s, PMAs, NDA, etc.). Review and approve product labeling and promotional materials to ensure regulatory adherence. Perform additional responsibilities to support short and long‑term enterprise initiatives as assigned. 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. 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. Education Bachelor's degree required. Position Level M5 Compensation The pay range is $157,500 – $262,500. Base pay may be supplemented by an annual bonus or long‑term incentive opportunities depending on performance, experience and skills. The pay is compliant with applicable regulations. Equal Employment Opportunity Statement McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) View email address on click.appcast.io or (Canada) View email address on click.appcast.io. Resumes or CVs submitted to this email box will not be accepted. #J-18808-Ljbffr McKesson Corporation