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.

This is a regulatory entry level professional position and includes both formal and on-the-job training programs.

Position supports the Regulatory Manager as part of the QA/RA Dept by maintaining product compliance aspect such as temperature management, DSCSA Suspect Product Obligations and Serialization requirements, Import/Export of Product, and FDA regulatory compliance.

Key Responsibilities:

● Conducting/Maintaining due-diligence and reviewing SAP, forms, and processes

● Maintaining Import/Export documents

● Ensuring FDA Readiness documents are complete and accurate

● Product Verification

●Ensuring DSCSA adherence and compliance.

• Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities.
• Manages complaint cases brought to regulatory authorities and process improvements to avoid future complaints.
• Advances organization positions with internal and external parties.
• Prepares and sponsors testimony to governmental or regulatory agencies.
• Documents internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
• Prepare materials for submission to regulatory agencies.
• Conduct employee regulatory training.
• Interprets regulatory rules or rule changes and ensures that they are communicated.
• Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Track regulatory metrics.
• Participates in internal or external audits.
• Maintains technical files as necessary to obtain and sustain product approval.
• Recommends changes to company procedures in response to changes in regulations or standards.
• Any other duties as assigned.

KNOWLEDGE:

• Basic use and/or application of basic principles, theories, and concepts. Knowledge base generally acquired from university degree or equivalent coursework or Regulatory Career Streams.

PROBLEM COMPLEXITY:

• Provides resolutions to problems of limited scope and complexity. Uses readily available information and follows standard practices and procedures. Emphasis on learning.

MINIMUM EDUCATION & TYPICAL EXPERIENCE OR EQUIV. COMBINATION:

• Work is closely managed and reviewed regularly. Follows specific, outlined, and detailed procedures

Working Conditions: At home and/or Warehouse

Travel: Less than 10%

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

$23.40 - $39.00

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!