Advisor -Regulatory Compliance and Post Market

Advisor - Regulatory Compliance and Post Market – Eli Lilly and Company

Join Eli Lilly’s Regulatory Compliance and Post Market Compliance team to ensure GMP/GxP standards are maintained across inspection readiness, regulatory reporting, recall and product shortage activities worldwide.

Key Responsibilities

• Lead inspection readiness activities for PAI, PLI, surveillance, post‑approval, and for‑cause inspections of global health authorities.
• Act as a global CGMP expert, providing guidance on corporate audits, agency inspections, standard revisions and local manufacturing/process changes.
• Support health‑authority reporting (FAR, BPDR, OUS requirements, EUA reporting, DSCSA) and coordinate global recall and U.S. recall activities.
• Monitor and report U.S. product shortages, coordinate U.S.‑ and OUS‑product shortage notifications, and maintain product shortage documentation.
• Maintain drug and device establishment registrations, including annual updates and changes.
• Coordinate annual U.S. volume reporting.
• Assist with periodic recall/withdrawal simulations and train local recall coordinators.
• Provide information for periodic reviews and metrics.
• Keep abreast of industry trends and regulatory agency interpretations of GMP and other requirements.

Minimum Requirements

• Bachelor’s degree, preferably in Pharmacy, Chemistry, Engineering or another biological science.
• Minimum 5 years of relevant industry or health‑authority experience in technical services, manufacturing operations, quality assurance, quality control or regulatory affairs.

Preferred Qualifications

• Broad knowledge of GMP and quality systems for pharmaceutical manufacturing and marketing.
• Experience in data‑driven compliance assessment and global inspections.
• Strong compliance knowledge and excellent communication and presentation skills.
• Ability to work independently and collaboratively with minimal supervision.
• Significant experience supporting global inspections and compliance programs.

Compensation and Benefits

Base salary range: $126,000 – $204,600 USD. Full‑time employees are also eligible for a company bonus depending on performance. Lilly offers a comprehensive benefit program including 401(k), pension, health, dental, vision, prescription drug, flexible spending accounts, life insurance and additional wellness benefits.

EEO Statement

Lilly is proud to be an Equal Employment Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability or any other legally protected status.

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