Regulatory Affairs Manager

We are seeking a Regulatory Affairs Manager. We are seeking a Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas-Fort Worth Metroplex, Texas.

Other locations considered are: Arkansas, Illinois, Kansas, Louisiana, Mississippi, Missouri, Oklahoma.

This role's primary responsibility is to support the regional Director of Regulatory Affairs (DRA) by conducting customer due diligence assessments focused on McKesson's U.S. Pharmaceutical Distribution accounts and in accordance with McKesson's Controlled Substances Monitoring Program (CSMP). This will require interaction and partnership with internal teams, report writing and data analysis, and interaction with DRAs to evaluate findings from the aforementioned activities.

- Conduct customer site visits as necessary to support CSMP processes.

- Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.

- Review and analyze data to support due diligence efforts and identify/validate controlled substance trends and sourcing profiles.

- Prepare written reports to document reviews and statistical analysis.

- Engage with account managers and customers, as well as internal team personnel as needed to support the CSMP process.

- Drive CSMP process awareness and communication with Sales and individual Account Managers.

- Seek opportunities to improve CSMP operational excellence through people, processes, or technology.

Degree or equivalent and typically requires 4+ years of relevant experience.

Education Four-year degree in a related field or equivalent experience

- 4+ years of experience managing regulatory compliance in the pharmaceutical supply chain, with a focus on controlled substance compliance (Pharmacy, DEA experience, or law enforcement background preferred).

- Strong ability to learn quickly and adapt in fast-paced environments.

- Proven collaboration skills across cross-functional teams.

- In-depth knowledge of retail pharmacy operations, controlled substance compliance, and diversion control programs.

- Expertise in making data-driven, strategic decisions based on thorough analysis.

- Excellent relationship-building and people engagement skills.

- Working knowledge of Federal and State regulations related to controlled substance compliance.

- Excellent communication, collaboration, and influencing skills at all levels of the organization.

- Proficient interviewing and technical writing skills, attention to detail.

- Traditional office requirements. A large percentage of time performing computer-based work is required.

This role is a hybrid position if you live near DFW . The selected candidate is expected to work on-site at our Las Colinas office a minimum of two (2) days per week , with the remaining days worked remotely. Specific in-office days may be designated based on team needs and business priorities.

Work Authorization: Must be authorized to work in the U.S. Sponsorship is not available for this position