Regulatory Affairs Manager
This role will be responsible for multiple components of US Pharma’s Controlled Substance Monitoring Program (CSMP) focused on Retail National Accounts (RNA). This includes conducting customer due diligence processes as necessary for compliance to McKesson’s CSMP. This will require interaction and partnership with internal RNA teams, review of reports and analysis, interaction with DRAs and evaluation of findings from these activities. Duties include:
- Manage the standard CSMP due diligence processes to include onboarding, threshold change requests and various reviews for individual chain registrants.
- Support the DRA/Sr. DRA in chain level due diligence processes.
- Review and analyze chain data regularly to support due diligence efforts and identify/validate controlled substance trends and sourcing profiles.
- Engage with chain Regulatory/Compliance personnel as needed to support CSMP processes.
- Drive awareness and communication with the RNA Support Solutions and individual Account Managers.
- Seek opportunities to improve CSMP operational excellence through people, processes or technology.
Additional General Responsibilities:
- Assist Pharma business to manage, negotiate and respond to governmental inspections and any resulting violations, punitive actions or monetary fines.
- Provides input and, where required, presentations to legislative and regulatory bodies developing solutions or regulations on issues of public interest that impact pharmaceutical distribution, e.g. controlled substance monitoring.
- Results Orientation and Energy
- Leveraging Data and Analytics
- Communicating Effectively
- Building Relationships
- Mature Confidence and Integrity
- Assertiveness and Influence
Typical Minimum Qualifications
- Degree or equivalent
- Typically requires 4+ years of relevant experience.
- 4+ years’ experience with responsibility for regulatory compliance, in the pharmaceutical/industry, as well as experience as an effective team player.
- A depth of understanding of retail pharmacy operations, controlled substance compliance and diversion programs.
- The ability to make strategic and educated decisions leveraging data, analysis and information from a variety of sources.
- People management and relationship building skills.
- Possess working knowledge of Federal and State governmental regulations pertaining to the diversion of controlled substances.
- Four year degree in related field or equivalent experience.
Physical Requirements: 25-30% travel
McKesson is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAquisition@McKesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.
Join us at McKesson!
Job posted: 2020-07-14