{"id":2931583,"url":"https://alion.io/job/mckesson-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":4393,"name":"McKesson","domain":"mckesson.com","url":"https://alion.io/company/mckesson","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":77,"open_postings":37,"ghost_share":0,"stale_share":0.919,"repost_share":0,"time_to_fill_p50_days":23,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Shepherdsville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":77000,"max":128300,"currency":"USD","period":"year","gross":null,"usd_annual":128300},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Gmail","optional":false},{"name":"Microsoft Office","optional":false}],"status":"closed","first_seen_at":"2026-09-10T00:00:00Z","employer_posted_date":"2026-09-10","last_verified_at":"2026-10-29T23:03:20Z","board_verified":false,"closed_at":"2026-10-29T23:03:20Z","days_open":49,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":49},"description":"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.\nWhat 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.\nPosition Summary\nThe Regulatory Affairs Manager(P3), Complex Molecules & Specialized Distribution Programs, supports regulatory compliance for pharmaceutical products requiring enhanced, product-specific, or overlapping distribution controls within pharmaceutical logistics and third-party logistics operations. This role serves as an advanced professional contributor and operational regulatory subject matter expert for products that may be governed by multiple FDA, DEA, state board of pharmacy, manufacturer, quality, security, licensing, patient-safety, and distribution requirements.\nThe position supports specialty pharmaceuticals, biologics, Risk Evaluation and Mitigation Strategy (REMS) products, controlled substances, limited-distribution products, cell and gene therapies, and other complex therapies requiring specialized handling or compliance controls. The role translates regulatory and manufacturer requirements into practical operational processes, evaluates compliance risk, supports product onboarding and change implementation, investigates exceptions, and maintains inspection and audit readiness.\nThe position partners with Quality Assurance, Operations, Security, Customer Service, Licensing, Legal, Commercial, Technology, Supply Chain, and pharmaceutical manufacturers to support compliant execution across the product lifecycle.\nKey Responsibilities:\nComplex Product & Program Oversight\nServe as a regulatory resource for complex molecules and specialized distribution programs requiring enhanced or overlapping compliance controls.\n\nAssess product-specific obligations involving FDA, DEA, state pharmacy, manufacturer, quality, licensing, security, patient-safety, and distribution requirements.\n\nTranslate complex regulatory and manufacturer requirements into scalable operational controls, procedures, decision criteria, and monitoring activities.\n\nIdentify conflicts, gaps, dependencies, and unintended consequences where multiple regulatory or contractual requirements apply.\n\nEvaluate proposed process, system, facility, customer, or product changes for regulatory impact and recommend practical risk controls.\n\nProvide risk-based escalation and recommendations to leadership when requirements are unclear, conflicting, or operationally difficult to execute.\n\nREMS & Restricted Distribution Compliance\nSupport implementation and ongoing maintenance of manufacturer REMS and restricted-distribution program requirements within distribution and fulfillment operations.\n\nInterpret Elements to Assure Safe Use (ETASU), certification, enrollment, customer eligibility, distribution limitation, documentation, reporting, and attestation requirements.\n\nMonitor REMS-related exceptions, program metrics, customer eligibility outcomes, and recurring compliance trends.\n\nSupport manufacturer audits, governance meetings, program reviews, corrective actions, and remediation activities.\n\nAssist with development and revision of policies, SOPs, work instructions, job aids, and training materials supporting assigned programs.\n\nControlled Substance & Dual-Regulated Product Support\nSupport regulatory compliance activities for controlled substances handled by distribution or 3PL operations, particularly where additional REMS, restricted-distribution, or manufacturer controls apply.\n\nAssist with review and investigation of controlled substance shipping, inventory, order, documentation, security, theft, loss, discrepancy, or potential diversion events.\n\nSupport documentation used for DEA, state board of pharmacy, manufacturer, law enforcement, or internal notifications, as applicable.\n\nCoordinate with Licensing, Quality, Security, and Operations to evaluate customer eligibility, handling, storage, recordkeeping, and distribution requirements.\n\nIdentify regulatory risks created by overlapping controlled substance and product-specific obligations and recommend mitigation actions.\n\nProduct Onboarding, Commercialization & Change Management\nLead or support regulatory assessments for new specialty products, biologics, cell and gene therapies, limited-distribution products, and other complex therapies.\n\nIdentify applicable licensing, customer qualification, reporting, security, quality, chain-of-custody, storage, transportation, temperature-control, and distribution requirements.\n\nParticipate in cross-functional launch-readiness reviews and confirm that required controls, documentation, training, systems, and escalation paths are established before implementation.\n\nSupport implementation of manufacturer-specific programs and translate contractual compliance commitments into sustainable operating practices.\n\nAssess regulatory impact of program revisions, labeling or product-status changes, operating-model changes, new service offerings, and system enhancements.\n\nCoordinate updates to procedures, training, monitoring, and evidence of implementation when requirements change.\n\nRegulatory Monitoring, Investigations & Audit Readiness\nMonitor relevant regulatory and manufacturer program developments and perform documented impact assessments for assigned products and processes.\n\nInvestigate regulatory compliance concerns, customer complaints, operational deviations, and process failures involving complex or restricted products.\n\nLead or support root cause analysis and corrective and preventive action activities, including effectiveness monitoring.\n\nMaintain accurate documentation supporting regulatory interpretations, risk decisions, investigation outcomes, escalation rationale, and compliance assessments.\n\nSupport FDA, DEA, state board, manufacturer, client, and internal audits or inspections involving assigned programs.\n\nAnalyze recurring exceptions and trends to recommend preventive controls and program improvements.\n\nCross-Functional Leadership & Regulatory Guidance\nProvide clear, practical regulatory guidance and training to internal stakeholders supporting assigned products and programs.\n\nFacilitate cross-functional issue resolution when multiple regulatory, quality, operational, or contractual requirements intersect.\n\nCommunicate with manufacturers and external program administrators regarding requirements, implementation questions, compliance status, exceptions, and follow-up actions.\n\nInfluence stakeholders without direct authority and drive assigned actions to timely completion.\n\nParticipate in business-development and client-onboarding activities when specialized regulatory expertise is required.\n\nExperience & Qualifications:\nBachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or a related field; equivalent experience may be considered.\n\n3-5 years of relevant experience in regulatory affairs, quality assurance, pharmaceutical distribution, healthcare compliance, pharmaceutical manufacturing, or a related regulated environment.\n\nExperience interpreting regulatory, quality, manufacturer, or customer requirements and translating them into operational controls.\n\nExperience supporting pharmaceutical distribution, specialty pharmacy, wholesale distribution, manufacturer, or 3PL operations.\n\nDemonstrated ability to investigate complex issues, document risk-based decisions, and coordinate corrective actions across functions.\n\nExperience supporting REMS products, restricted-distribution programs, specialty pharmaceuticals, biologics, cell and gene therapies, or other complex therapies.\n\nKnowledge of DEA controlled substance regulations and state board of pharmacy requirements.\n\nFamiliarity with cold-chain, ultra-low-temperature, chain-of-custody, or specialty logistics requirements.\n\nExperience with product commercialization, launch readiness, regulatory change implementation, or manufacturer program onboarding.\n\nExperience interacting with pharmaceutical manufacturers, auditors, regulatory agencies, program administrators, or external business partners.\n\nRegulatory Affairs Certification (RAC), pharmacy technician certification, or a comparable professional credential.\n\nKnowledge, Skills & Abilities\nStrong working knowledge of pharmaceutical regulatory compliance and the operational controls used to support specialized distribution programs.\n\nAbility to interpret multiple overlapping regulatory, manufacturer, quality, licensing, and operational requirements as an integrated control framework.\n\nAbility to distinguish legal requirements, regulatory expectations, contractual commitments, and internal best practices.\n\nStrong analytical, investigative, technical-writing, documentation, and problem-solving skills.\n\nAbility to perform risk assessments, identify control gaps, and recommend practical and sustainable mitigation actions.\n\nExcellent written and verbal communication skills, including the ability to summarize complex issues for leadership, manufacturers, clients, and cross-functional partners.\n\nAbility to manage multiple priorities, lead workstreams, drive follow-up, and influence stakeholders without direct authority.\n\nProficiency with compliance systems, document management tools, investigation records, metrics, and Microsoft Office applications.\n\nWe 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.\nOur Base Pay Range for this position\n$77,000 - $128,300McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:\nMcKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.\nMcKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.\nMcKesson job postings are posted on our career site: careers.mckesson.com.\nMcKesson is an Equal Opportunity Employer\nMcKesson 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.\nMcKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. 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