Regulatory Affairs Associate Specialist

McKesson • Irving, TX

20h • $25 - $42 • Remote

About The Position

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. Regulatory Affairs Associate Specialist – Central Support We are seeking a Regulatory Affairs Associate Specialist. This role is a work-from-home position in the Dallas-Fort Worth Metropolitan area . If the applicant is located outside of the area, they must be willing to relocate. As a Central Support Team member, this role’s primary responsibility is to support McKesson’s Controlled Substances Monitoring Program (CSMP). The duties for this position include, but are not limited to, providing administrative support to the Regulatory Affairs Department; upporting the Manager of Central Support in the processing of regulatory documentation; conducting initial customer due diligence; and using tools, reports, and data in accordance with CSMP policies and procedures. In addition, this position supports projects ranging in size, complexity, and effort that directly impact the CSMP. This will require collaboration with internal partners, regulatory affairs team members, and customers.

Requirements

• Typically, minimum 0-2 years of relevant experience. May have degree or equivalent.
• Degree or equivalent in 2+ years of controlled substance regulatory compliance experience strongly preferred.
• Experience in controlled substance regulatory compliance.
• Understanding of project management and process development.
• Demonstrates the ability to multitask.
• Demonstrates the ability to succeed in a high-stress environment.
• Possess strong communication, collaboration, and influencing skills.
• Strong writing and analytical skills.
• Possess working knowledge of federal and state government laws and regulations related to controlled substances.
• Intermediate to advanced MS Office (Word, Outlook, Excel & PowerPoint) skills.

Nice To Haves

• Adaptable to changing environment/technology.
• Result orientated and assertive attitude.
• Team building qualities.
• Mature confidence and integrity.
• Degree preferred.

Responsibilities

• Organize and coordinate incoming regulatory requests, which includes monitoring and ensuring completeness of documentation and creating and maintaining regulatory due diligence files in accordance with CSMP policies and procedures.
• Participate in due diligence reviews that may include conducting state license and DEA registration checks, open-source checks, and use of customer-specific data.
• Drafting detailed due diligence reports or other related documents.
• Frequently interact with Regulatory Affairs team members to support CSMP process.
• Liaison with customers or McKesson Sales personnel on behalf of the Regulatory Affairs Department to secure additional information as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees