Sr. Director, Regulatory Affairs

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 tomorrows 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.

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 riskmitigation 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 longterm 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 AIenabled regulatory intelligence documentation and compliance tools including an understanding of associated risks related to data integrity bias validation and explainability. Ability to translate AIgenerated insights into defensible regulatory strategies ensure compliance with FDA DEA and state regulatory expectations and educate crossfunctional partners on compliant AI use.

Education:

• Bachelors degree required

About MMS

McKesson Medical-Surgical (MMS) which is expected to become Wellverse in early 2027 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 8000 employees a network of 15 distribution centers and approximately 900 delivery vehicles we collaborate with more than 2200 leading manufacturers and serve over 200000 customer accounts across the U.S. Our catalog includes more than 270000 SKUs of branded and private-label medical-surgical products from bandages to specialty pharmaceuticals and COVID-19 tests.

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 McKessons 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 pleaseclick here.

Our Base Pay Range for this position

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