Advisor – Regulatory Compliance and Post Market
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Position Overview
At Lilly we unite caring with discovery to make life better for people around the world. This role supports GMP/GxP support across regulatory reporting and inspection support for the RCPMR (Regulatory Compliance and Post Market Reporting) team. Key duties include inspections, health authority reporting, recall and shortage activities, product registration, volume reporting and personal development.
Responsibilities
* Lead inspection readiness activities and global compliance expertise for corporate audits, agency inspections and standard revisions.
* Serve as a global compliance CGMP expert providing feedback for audit preparation and local manufacturing process changes.
* Work with multiple stakeholders to ensure health authority reporting (FAR, BPDR, OUS requirements) and meet all global regulations.
* Support the coordination of US product recall and withdrawal activities and participate in periodic product withdrawal/recall simulations.
* Coordinate product shortage reporting for US and OUS and generate FDA reporting or notification to OUS regulatory agencies.
* Determine information required for drug and device establishment registration and update registrations for all US marketed product manufacturers.
* Coordinate and execute annual volume reporting for US and provide information for periodic reviews or metrics.
* Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements and continue to gain knowledge vital to provide a greater understanding of GxP requirements.
Qualifications
* Bachelor’s degree preferred in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
* Minimum of 5 years relevant industry or health authority experience in quality assurance, quality control or regulatory affairs technical services, manufacturing operations or related areas.
Preferred Qualifications
* Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing.
* Expertise in data driven approaches to assess site compliance.
* Experience in Quality Assurance or GxP function and strong compliance knowledge.
* Excellent communication and presentation skills, ability to deliver constructive feedback.
* Skilled in interpreting and applying standards to diverse situations with strong problem‑solving ability.
* Ability to work independently and collaboratively with minimal supervision and significant experience supporting global inspections and compliance programs.
Additional Information
* Maintain awareness of regulatory and industry trends and ensure corporate standards remain current.
* Flexibility to effectively prioritize work activities to meet regulated timelines.
* Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
* Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs).
* Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters.
Compensation and Benefits
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including 401(k) participation, pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits, life and death insurance, and well‑being benefits such as employee assistance, fitness, and employee clubs.
EEO and Employment
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Lilly is a proud EEO 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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