Regulatory Affairs Specialist

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Legal & ComplianceRegulatory Affairs Specialist

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Quick Summary

Overview

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products,

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Legal & ComplianceRegulatory Affairs Specialist

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.

Responsibilities

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Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or a related field; equivalent experience may be considered.

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3-5 years of relevant experience in regulatory affairs, quality assurance, pharmaceutical distribution, healthcare compliance, pharmaceutical manufacturing, or a related regulated environment.

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Experience interpreting regulatory, quality, manufacturer, or customer requirements and translating them into operational controls.

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Experience supporting pharmaceutical distribution, specialty pharmacy, wholesale distribution, manufacturer, or 3PL operations.

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Demonstrated ability to investigate complex issues, document risk-based decisions, and coordinate corrective actions across functions.

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Experience supporting REMS products, restricted-distribution programs, specialty pharmaceuticals, biologics, cell and gene therapies, or other complex therapies.

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Knowledge of DEA controlled substance regulations and state board of pharmacy requirements.

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Familiarity with cold-chain, ultra-low-temperature, chain-of-custody, or specialty logistics requirements.

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Experience with product commercialization, launch readiness, regulatory change implementation, or manufacturer program onboarding.

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Experience interacting with pharmaceutical manufacturers, auditors, regulatory agencies, program administrators, or external business partners.

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Regulatory Affairs Certification (RAC), pharmacy technician certification, or a comparable professional credential.

Requirements

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$77,000 - $128,300

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McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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 (United States) Disability_Accommodation@McKesson.com or (Canada) Accessibility@mckesson.ca. Resumes or CVs submitted to this email box will not be accepted.