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.
Key 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.
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
About 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.
Looking Ahead : A New Chapter for MMSMcKesson has announced its intent to separate MMS into an independent company - an exciting evolution that builds on MMS's strong foundation and proven leadership in the Alternate Care space. As a standalone company, MMS would be positioned to unlock new opportunities to innovate, grow and lead with even greater agility and focus. We will also continue to be one of the largest medical-surgical distributors in the U.S., with over $11B in annual sales. This separation would accelerate our mission and empower us to shape a future defined by customer-centricity, bold thinking and operational excellence. For job seekers, it's a unique moment to join a team that's already making a meaningful impact and leading the way in shaping the future of healthcare delivery in Alternate Care settings - with even greater opportunity ahead as we prepare to become an independent company.
Position Level - M5
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 McKesson's 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, please click here.
Our Base Pay Range for this position$157,500 - $262,500
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