Regulatory Affairs Specialist

Regulatory Affairs Manager

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Position Summary

The 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.

The 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.

The 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.

Key Responsibilities:

• Serve as a regulatory resource for complex molecules and specialized distribution programs requiring enhanced or overlapping compliance controls.
• Assess product-specific obligations involving FDA, DEA, state pharmacy, manufacturer, quality, licensing, security, patient-safety, and distribution requirements.
• Translate complex regulatory and manufacturer requirements into scalable operational controls, procedures, decision criteria, and monitoring activities.
• Identify conflicts, gaps, dependencies, and unintended consequences where multiple regulatory or contractual requirements apply.
• Evaluate proposed process, system, facility, customer, or product changes for regulatory impact and recommend practical risk controls.
• Provide risk-based escalation and recommendations to leadership when requirements are unclear, conflicting, or operationally difficult to execute.

REMS & Restricted Distribution Compliance

• Support implementation and ongoing maintenance of manufacturer REMS and restricted-distribution program requirements within distribution and fulfillment operations.
• Interpret Elements to Assure Safe Use (ETASU), certification, enrollment, customer eligibility, distribution limitation, documentation, reporting, and attestation requirements.
• Monitor REMS-related exceptions, program metrics, customer eligibility outcomes, and recurring compliance trends.
• Support manufacturer audits, governance meetings, program reviews, corrective actions, and remediation activities.
• Assist with development and revision of policies, SOPs, work instructions, job aids, and training materials supporting assigned programs.

Controlled Substance & Dual-Regulated Product Support

• Support regulatory compliance activities for controlled substances handled by distribution or 3PL operations, particularly where additional REMS, restricted-distribution, or manufacturer controls apply.
• Assist with review and investigation of controlled substance shipping, inventory, order, documentation, security, theft, loss, discrepancy, or potential diversion events.
• Support documentation used for DEA, state board of pharmacy, manufacturer, law enforcement, or internal notifications, as applicable.
• Coordinate with Licensing, Quality, Security, and Operations to evaluate customer eligibility, handling, storage, recordkeeping, and distribution requirements.
• Identify regulatory risks created by overlapping controlled substance and product-specific obligations and recommend mitigation actions.

Product Onboarding, Commercialization & Change Management

• Lead or support regulatory assessments for new specialty products, biologics, cell and gene therapies, limited-distribution products, and other complex therapies.
• Identify applicable licensing, customer qualification, reporting, security, chain-of-custody, storage, transportation, temperature-control, and distribution requirements.
• Participate in cross-functional launch-readiness reviews and confirm that required controls, documentation, training, systems, and escalation paths are established before implementation.
• Support implementation of manufacturer-specific programs and translate contractual compliance commitments into sustainable operating practices.
• Assess regulatory impact of program revisions, labeling or product-status changes, operating-model changes, new service offerings, and system enhancements.
• Coordinate updates to procedures, training, monitoring, and evidence of implementation when requirements change.

Regulatory Monitoring, Investigations & Audit Readiness

• Monitor relevant regulatory and manufacturer program developments and perform documented impact assessments for assigned products and processes.
• Investigate regulatory compliance concerns, customer complaints, operational deviations, and process failures involving complex or restricted products.
• Lead or support root cause analysis and corrective and preventive action activities, including effectiveness monitoring.
• Maintain accurate documentation supporting regulatory interpretations, risk decisions, investigation outcomes, escalation rationale, and compliance assessments.
• Support FDA, DEA, state board, manufacturer, client, and internal audits or inspections involving assigned programs.
• Analyze recurring exceptions and trends to recommend preventive controls and program improvements.

Cross-Functional Leadership & Regulatory Guidance

• Provide clear, practical regulatory guidance and training to internal stakeholders supporting assigned products and programs.
• Facilitate cross-functional issue resolution when multiple regulatory, quality, operational, or contractual requirements intersect.
• Communicate with manufacturers and external program administrators regarding requirements, implementation questions, compliance status, exceptions, and follow-up actions.
• Influence stakeholders without direct authority and drive assigned actions to timely completion.
• Participate in business-development and client-onboarding activities when specialized regulatory expertise is required.

Experience & Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or a related field; equivalent experience may be considered.
• 3-5 years of relevant experience in regulatory affairs, quality assurance, pharmaceutical distribution, healthcare compliance, pharmaceutical manufacturing, or a related regulated environment.
• Experience interpreting regulatory, quality, manufacturer, or customer requirements and translating them into operational controls.
• Experience supporting pharmaceutical distribution, specialty pharmacy, wholesale distribution, manufacturer, or 3PL operations.
• Demonstrated ability to investigate complex issues, document risk-based decisions, and coordinate corrective actions across functions.
• Experience supporting REMS products, restricted-distribution programs, specialty pharmaceuticals, biologics, cell and gene therapies, or other complex therapies.
• Knowledge of DEA controlled substance regulations and state board of pharmacy requirements.
• Familiarity with cold-chain, ultra-low-temperature, chain-of-custody, or specialty logistics requirements.
• Experience with product commercialization, launch readiness, regulatory change implementation, or manufacturer program onboarding.
• Experience interacting with pharmaceutical manufacturers, auditors, regulatory agencies, program administrators, or external business partners.
• Regulatory Affairs Certification (RAC), pharmacy technician certification, or a comparable professional credential.

Knowledge, Skills & Abilities

• Strong working knowledge of pharmaceutical regulatory compliance and the operational controls used to support specialized distribution programs.
• Ability to interpret multiple overlapping regulatory, manufacturer, quality, licensing, and operational requirements as an integrated control framework.
• Ability to distinguish legal requirements, regulatory expectations, contractual commitments, and internal best practices.
• Strong analytical, investigative, technical-writing, documentation, and problem-solving skills.
• Ability to perform risk assessments, identify control gaps, and recommend practical and sustainable mitigation actions.
• Excellent written and verbal communication skills, including the ability to summarize complex issues for leadership, manufacturers, clients, and cross-functional partners.
• Ability to manage multiple priorities, lead workstreams, drive follow-up, and influence stakeholders without direct authority.
• Proficiency with compliance systems, document management tools, investigation records, metrics, and Microsoft Office applications.

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