Advisor -Regulatory Compliance and Post Market

Advisor - Regulatory Compliance and Post Market

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Position Brand Description

This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. Duties include supporting health authority reporting (FAR, BPDR, OUS requirements), global recall and US recall activities, monitoring and reporting of US product shortages, coordinating product shortage notifications for OUS countries, and updating drug and device establishment registrations for changes as required.

Key

Objectives / Deliverables

In this role the individual provides support that they give to the different programs, with a primary focus on compliance support. Other duties will depend on business needs.

Compliance Support

• Lead inspection readiness activities.
• Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.
• Proficient in the application and use of machine learning and analytical tools to maintain continuous inspection readiness.

US and Global Regulatory Reporting

• Work with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements.

Global and US Recall / Market Withdrawal

• Support coordination of US product recall and withdrawal activities.
• Participate in periodic product withdrawal/recall simulations.
• Consult and train local recall coordinators to assure understanding of the process for product removal.
• Monitor recall activities of partner organizations globally.
• Provide information for use in various periodic reviews or metrics.

Global and US Product Shortage

• Coordinate and execute product shortage reporting for US and OUS, networking with supply chain, global quality leaders, senior management, legal, regulatory, global patient safety, and qualified persons at affiliates.
• Generate, submit and maintain product shortage documentation following local procedure.
• Provide information for use in various periodic reviews or metrics.

Drug and Device Establishment Registration

• Determine information required for drug and device establishment registration for all manufacturers of US marketed products.
• Update registrations for changes as required, including completion of annual registrations.

US Volume Reporting

• Coordinate and execute annual volume reporting for the US.
• Provide information for use in various periodic reviews or metrics.

Personal Development and Shared Learning

• Stay continually aware of current industry trends and regulatory agency interpretations of GMP and other relevant requirements.
• Continue to gain knowledge vital to provide a greater understanding of GxP requirements.
• Participate in applicable external industry groups and forums.

Minimum Requirements

• Bachelor’s degree – Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
• Minimum of 5 years relevant industry or health authority experience in areas that may include 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.
• Expertise in data‑driven approaches to assess site compliance.
• Experience in quality assurance or GxP functions.
• Strong compliance knowledge.
• Excellent communication and presentation skills; ability to deliver constructive feedback.
• Skill in interpreting and applying standards to diverse situations with strong problem‑solving ability.
• Ability to work independently and collaboratively with minimal supervision.
• Significant experience supporting global inspections and compliance programs.

Other Information

• Maintain awareness of regulatory and industry trends to keep corporate standards current.
• Flexibility to effectively prioritize work activities to meet regulated timelines.
• Ability to influence and negotiate with peers, immediate supervisors, site…