Regulatory Affairs Manager

About the role

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.

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 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.

Requirements

• Minimum Requirement: Degree or equivalent and typically requires 4+ years of relevant experience.
• Education: Four-year degree in a related field or equivalent experience.
• Critical Skills: 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. Proficiency in MS Office (Word, PowerPoint, Excel).
• 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. Experience with Tableau, SAP, and Salesforce. Results Orientation and Energy. Building Relationships. Mature Confidence and Integrity. Assertiveness and Influence.

Qualifications

• Physical Requirements: Traditional office requirements. A large percentage of time performing computer-based work is required. 10% travel for client visits.