Regulatory Affairs Associate Specialist – Central Support

McKesson Pharmacy Automation; Irving (TX); Remote; Full time

Job summary

McKesson Pharmacy Automation is seeking a Regulatory Affairs Associate Specialist to support its Controlled Substances Monitoring Program. This remote position requires strong regulatory compliance experience and project management skills, along with the ability to effectively collaborate and communicate in a high-stress environment.

Qualifications

• 0-2 years of relevant experience.
• Understanding of federal and state laws related to controlled substances.
• Strong writing and analytical skills.

Responsibilities

• Organize incoming regulatory requests and maintain due diligence files.
• Conduct due diligence reviews and draft reports.
• Collaborate with internal partners in support of regulatory processes.

Skills

Controlled substance regulatory compliance

Project management

Communication

Analytical skills

Collaboration

Multitasking

Education

Degree preferred

Tools

MS Office

Job description

Regulatory Affairs Associate Specialist – Central Support

Regulatory Affairs Associate Specialist – Central Support

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.

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; supporting 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.

Key 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.
  
  

Minimum Requirement

Typically, minimum 0-2 years of relevant experience. May have degree or equivalent.

Critical Skills

• 2+ years of controlled substance regulatory compliance experience.
• 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.
  
  

Additional Skills

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

Physical Requirements

• Traditional office requirements. A large percentage of time performing computer-based work is required.
• Less than 10% travel or as needed
  
  

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, please click here.

Our Base Pay Range for this position

$24.99 - $41.65

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!

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

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