Regulatory Affairs Manager

Davita Inc.; Town of Texas (WI); Remote; USD 82,000 - 138,000; Full time

Job summary

A leading company in healthcare is seeking a Regulatory Affairs Manager for a remote position in Texas. This role will involve conducting customer assessments, supporting regulatory compliance, and improving operational excellence. The ideal candidate should have a degree and extensive experience in regulatory affairs, particularly in the pharmaceutical supply chain. Join us and be part of our mission to provide quality care.

Qualifications

• Typically requires 4+ years of relevant experience.
• In-depth understanding of regulatory compliance in the pharmaceutical industry.
• Possess knowledge of Federal and State regulations.

Responsibilities

• Conduct customer due diligence assessments.
• Prepare written reports to document evaluations.
• Engage with account managers and customers.

Skills

Regulatory compliance

Data analysis

Report writing

Analytical Skills

Communication

Education

Degree or equivalent

Tools

MS Office

Tableau

SAP

Salesforce

Job description

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

Current Need *TX Remote*
We are seeking a Regulatory Affairs Manager. This role is a remote work-from-home position to be located in Texas.

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, data analysis, and interaction with program leadership 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 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.

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

Critical Skills

• Multiple years' experience with responsibility for regulatory compliance in the supply chain for the pharmaceutical industry (Controlled substance compliance experience, Pharmacy, DEA experience, or law enforcement background a plus).

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

• Possess a working knowledge of Federal and State governmental regulations pertaining to controlled substance compliance.

• Advanced proficiency with MS Office (Word, PowerPoint, Excel).

• Experience with Tableau, SAP, and Salesforce.

Additional Skills

• Ability to make strategic, logic-based, and educated decisions leveraging data, analysis, and information from a variety of sources.

• People engagement and relationship building skills.

• Ability to learn quickly and work effectively in fast-paced environments.

• Ability to collaborate with various teams.

• 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, pleaseclick here.

Our Base Pay Range for this position

$82,700 - $137,900

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.

Join us at McKesson!