Advisor -Regulatory Compliance and Post Market

Role Summary

Advisor - Regulatory Compliance and Post Market is responsible for providing GMP/GxP support across regulatory reporting and inspection activities. The role covers inspections for global Health Authorities, HA reporting, and support for global recalls, product shortages, and establishment registrations. Primary focus is compliance support with additional duties as needed by the business.

Responsibilities

• Lead inspection readiness activities
• Serve as a global CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes
• Apply machine learning and analytical tools to remain in a state of inspection readiness

• Support US and global regulatory reporting of quality/safety/compliance issues, coordinating with stakeholders to meet global regulatory requirements

• Coordinate US product recall and withdrawals, participate in recall simulations, and train local recall coordinators on the process
• Monitor recall activities of partner organizations globally and provide information for periodic reviews or metrics

• Coordinate and execute product shortage reporting for US and OUS, document decisions for FDA or OUS regulatory notifications, and maintain related documentation
• Provide information for periodic reviews or metrics

• Determine information required for drug and device establishment registrations for US-marketed products and update registrations as needed

• Coordinate and execute annual US volume reporting and provide information for periodic reviews

• Maintain awareness of industry trends and GMP interpretations, gain knowledge of GxP requirements, and participate in external industry groups

Qualifications

• Minimum Requirements
  • Bachelor‚Äôs degree ‚Äî preferred in Pharmacy, Chemistry, Engineering, or other biological sciences
  • Minimum of 5 years of relevant industry or health authority experience in technical services, manufacturing operations, quality assurance, quality control, or regulatory affairs
• Additional Preferences
  • Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing
  • Data-driven approaches to assess site compliance
  • Experience in Quality Assurance or GxP functions
  • Strong compliance knowledge with excellent communication and presentation skills
  • Ability to interpret and apply standards to diverse situations with strong problem-solving skills
  • Ability to work independently and collaboratively with minimal supervision
  • Significant experience supporting global inspections and compliance programs

Education

• Bachelor‚Äôs degree ‚Äî preferred in a scientific field such as Pharmacy, Chemistry, Engineering, or other biological sciences

Additional Requirements

• Ability to travel domestically and internationally when required (estimated 25%, may increase based on business needs)
• Role can be remote or based at any Lilly site/affiliate or corporate headquarters; preference for a Lilly site/affiliate or headquarters