Regulatory Affairs Manager

We are seeking a Regulatory Affairs Manager. This role is a remote work-from-home position to be located preferably in either Florida or Georgia.

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 Pharmaceutical Solutions and Services 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.

Key Responsibilities

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 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.

MinimumRequirement

Degree or equivalent experience. Typically requires 6+ years of professional experience and 0-2 years of supervisory experience

Education

Four-year degree in related field or equivalent experience

Critical Skills

5+ 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.

Advanced proficiency in MS Office (Word, PowerPoint, Excel).

Experience with Tableau, SAP, and Salesforce.

Additional Skills

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

Proficient interviewing and technical writing skills, attention to detail

Strong Analytical Skills

Results Orientation and Energy

Building Relationships

Mature Confidence and Integrity

Assertiveness and Influence

Travel

20% Travel

Physical Requirements

General Office demands

Ability to operate a laptop

Must be authorized to work in the US. Sponsorship is not available for this position.

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

Our Base Pay Range for this position

$79,700 - $132,800