Advisor/Senior Advisor - Regulatory Compliance and Post Market Reporting

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

This position is responsible for providing support across the different regulatory reporting and inspection support that is provided by the Regulatory Compliance & Post Market Reporting team. This includes but is not limited to; all facets of PAI/PLI inspections, US FDA field alert, Biological product, illegitimate product, global regulatory reporting, support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as required including completion of annual changes, gathering and analyzing information for inspections, annual product reviews, periodic reviews, site compliance reports

Key Objectives/Deliverables:

In this role the individual works with the Process Owners across all Regulatory Reporting programs. The support that they provide to the different programs are as shown below.

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.

• US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues

• Global and US Recall / Market Withdrawal activities

• Global …