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 managed by the Regulatory Compliance and Post Market Reporting team. Duties include inspections with global Health Authorities, HA reporting, and support for global recalls, product shortages, and establishment registrations. The role emphasizes compliance support and may involve travel to domestic and international sites.

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 and use machine learning and analytical tools to stay in a state of inspection readiness
• Coordinate and execute actions related to US and global regulatory reporting of quality/safety/compliance issues
• Collaborate with stakeholders to ensure HA reporting as required to meet global regulations/requirements
• Coordinate US product recall and withdrawals, participate in recall simulations, and train local recall coordinators
• 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, including communication with Supply Chain and regulatory colleagues
• Determine information for drug and device establishment registrations and update registrations as required
• Coordinate and execute annual US volume reporting and provide information for periodic reviews
• Stay aware of industry trends and regulatory interpretation of GMP and GxP requirements; participate in external industry groups

Qualifications

• Required: Bachelor‚Äôs degree (preferred in Pharmacy, Chemistry, Engineering or other biological sciences)
• Required: Minimum of 5 years of relevant industry or health authority experience in areas such as technical services, manufacturing operations, quality assurance, quality control, or regulatory affairs
• Preferred: Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing
• Preferred: Expertise in data-driven approaches to assess site compliance
• Preferred: Experience in Quality Assurance or GxP function
• Preferred: Strong compliance knowledge and excellent communication/presentation skills

Skills

• Excellent communication and presentation skills; ability to deliver constructive feedback
• Strong problem-solving ability and ability to interpret and apply standards to diverse situations
• Ability to work independently and collaboratively with minimal supervision
• Experience supporting global inspections and compliance programs
• Proficiency in data-driven regulatory compliance approaches

Education

• Bachelor‚Äôs degree in a scientific field (e.g., Pharmacy, Chemistry, Engineering) or related biological sciences

Additional Requirements

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