Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist plays a critical role in the support of the CSMP team. This position will provide support for the enhancement and maintenance of the Regulatory Affairs Controlled Substances Monitoring Program (CSMP) and collaborate with internal McKesson teams. The RAS will have responsibility for coordinating, tracking, and reporting on functions related to McKesson’s legal and regulatory obligations for controlled substances distribution, while also supporting the Regulatory Affairs training program, departmental policies and procedures, CSMP process management efforts and other administrative responsibilities. The position will report to the Sr. Director, Regulatory Affairs, Operational Support, and be expected to work cross-functionally with various McKesson departments.

Key Responsibilities

• Support the development, delivery, and memorialization of CSMP training materials.
• Develop knowledge and understanding of CSMP regulatory requirements and processes to assist in training development.
• Assist in review and version control process for training content, SOPs, Work Instructions, and other projects related to the CSMP.
• Use knowledge of learning technologies to propose learning solutions that result in an effective curriculum for the CSMP learning environment.
• Coordinate with various internal stakeholders to obtain requested information and analyses.
• Support Regulatory Affairs team members with systems and resource access during onboarding/offboarding.
• Assist in evaluating and tracking potential system-related issues and projects.
• Seek opportunities for process improvements to enhance the efficiency and effectiveness of department initiatives.
• Other duties as assigned.

Minimum Requirements

• 6+ years of experience in training and development. Experience in compliance, legal, or regulatory affairs.

Critical Skills

• Ability to use project management and reporting tools, including Smartsheet, Salesforce and Share Point as well as Advanced MS Office 365 (Word, PowerPoint, Excel) skills.
• 4+ years Training/Development/Instructional Design experience using tools like Articulate, RISE, Vyond, Eleven Labs and other training tools and software.
• Strong written and oral communication skills, including the ability to communicate to all organizational levels.
• Demonstrated ability to adjust to changing priorities.
• A results-oriented approach and attention to detail.

Additional Skills

• Experience delivering virtual presentations/training.
• Provide solutions to a diverse range of complex problems.
• Ability to work independently and in a team environment.
• Ability to work under pressure and meet competing deadlines.
• Strong time management skills.
• Prior experience in compliance or regulatory functions.
• Demonstrated good judgment and decision-making.

Education

• Bachelor’s degree (preferred) or equivalent, and minimum of four (4) years relevant work experience in building, enhancing, and maintaining healthcare compliance programs.

This position includes both formal and on-the-job training programs.

Physical Requirements

• Office environment.
• Less than 10% travel as needed.

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, pleaseclick here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position $82,200 – $137,000 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 [email protected]. 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!