Regulatory Affairs Lead Director

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The Lead Director, Regulatory Affairs ("Lead Director") will play a crucial role in supporting McKesson's Controlled Substances Monitoring Program (CSMP). This position involves collaborating with the regional Senior Director of Regulatory Affairs to manage customer due diligence reviews, with a focus on the Community Pharmacy and Health (CP&H) segment within the Pharmaceutical Solutions & Services (PSaS) business unit. The Lead Director will ensure the uniform application of all policies and procedures and serve as the primary training contact for the regional team. Reporting directly to McKesson's Senior Director of Regulatory Affairs, this role is integral to maintaining compliance and operational excellence.

Key Responsibilities

• Direct and guide customer due diligence reviews to ensure compliance with CSMP policies and procedures, applicable laws and regulations governing the wholesale distribution of controlled substances, and other legal requirements or agreements.

• Oversee completion of due diligence reviews of various types by CSMP personnel (according to designated authority under CSMP policies and procedures). The Lead Director may also assist with conducting customer interviews depending on the facts and circumstances of a particular due diligence review.

• Assist department leadership in driving performance and productivity of team members who conduct customer due diligence.

• Act as the regional CSMP training contact for both new hires and existing team members, consistently developing and effectively delivering personalized training sessions and materials.

• Review CSMP reports, analytics, and other data that aid with the identification and direction of customer due diligence workstreams and promote awareness of customer and geographical trends.

• Partner with department leadership to drive ongoing development of the CSMP by identifying trends, refining policies and procedures, and developing of CSMP-related training programs.

Minimum Requirement

Degree or equivalent and typically requires 10+ years of relevant experience. Less years required if has relevant Master's or Doctorate qualifications.

Education

Undergraduate degree or equivalent experience.

Critical Skills

• A minimum of 10 years of professional experience in controlled substance compliance, pharmacy practice or diversion or health care law enforcement, preferably in a health care organization, including experience in a training or quality role.

• Ability to prioritize and manage multiple ongoing initiatives simultaneously within a dynamic and evolving regulatory and business environment while maintaining operational efficiency and achieving strategic objectives.

• Proven track record of handling sensitive information with the utmost confidentiality to protect organizational integrity and maintaining stakeholder trust.

• Sound judgment and decision-making skills to evaluate complex scenarios and make informed, strategic decisions that align with organizational goals.

• Excellent attention to detail and a commitment to precision and accuracy in all tasks to ensure compliance with regulations and minimize risks associated with errors.

• Effective written and verbal communication skills, demonstrated by the ability to articulate complex ideas, thoughts, and information in a clear, logical, and concise manner for diverse audience.

• Strong analytical and organizational skills, coupled with a robust problem-solving mindset with the ability to dissect complex problems, devise innovative solutions, and implement them efficiently to drive organizational success.

Additional Knowledge & Skills

• Specific knowledge of the Controlled Substances Act (CSA) and equivalent/related state requirements.

Working Conditions

• Must be authorized to work in the US unrestricted - This position is not eligible for sponsorship.

• Must be able to travel 15%

• Remote/Home Office work environment.

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, pleaseclick here.

Our Base Pay Range for this position

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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