Advisor -Regulatory Compliance and Post Market

Role Summary

This position provides GMP/GxP support across regulatory reporting and inspection activities within the Regulatory Compliance and Post Market Reporting (RCPMR) team. Responsibilities include inspections for global Health Authorities, regulatory reporting, and support for global recalls, product shortages, and establishment registrations. The role focuses on compliance support, with other duties assigned based on business needs.

Responsibilities

• Lead inspection readiness activities and provide CGMP expertise for audits, agency inspections, and changes in processes.
• Apply machine learning and analytical tools to maintain ongoing inspection readiness.
• Coordinate US and global regulatory reporting of quality, safety, and compliance issues, and ensure HA reporting meets global regulations.
• Coordinate US product recalls and withdrawals, participate in recall simulations, train local recall coordinators, and monitor global recall activities.
• Coordinate and execute product shortage reporting for US and international markets; document decisions for FDA reporting or OUS notifications.
• Determine information required for drug and device establishment registrations and maintain annual registrations.
• Coordinate and execute annual US volume reporting and provide data for periodic reviews.
• Maintain awareness of industry trends and GMP interpretations; pursue ongoing GxP knowledge; engage with external industry groups.

Qualifications

• Required: Bachelor’s degree (preferred in Pharmacy, Chemistry, Engineering or related scientific field); minimum of 5 years of relevant industry or health authority experience in areas such as technical services, manufacturing operations, quality assurance/control, or regulatory affairs.
• Preferred: Broad knowledge of GMPs and quality systems; experience in QA or GxP functions; strong compliance knowledge; excellent communication and presentation skills; strong problem-solving ability; ability to work independently and with minimal supervision; experience supporting global inspections and compliance programs.

Skills

• Strong knowledge of GMPs and quality systems; data-driven approach to assess site compliance.
• Excellent communication and presentation skills; ability to provide constructive feedback.
• Analytical mindset with ability to interpret standards across diverse situations.
• Independent and collaborative work style; ability to manage multiple priorities.
• Experience with global inspections and compliance programs.

Education

• Bachelor’s degree in a scientific field (preferred: Pharmacy, Chemistry, Engineering or related biological sciences).

Additional Requirements

• Willingness to travel domestically and internationally (estimated 25%, may vary).
• Role can be remote or based at any Lilly site/affiliate; preference for a site/affiliate or corporate headquarters.