Advisor -Regulatory Compliance and Post Market

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.

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. This includes but is not limited to; all facets of inspections (PAI/PLI/Surveillance/Post-approval/for-cause) for all global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). Provide 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 the need arises including completion of annual changes.

Key Objectives/Deliverables:

In this role the individual provides support that they provide to the different programs are as shown below. Primary focus is 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 application and use of Machine Learning and analytical tools to being continuously in a state of inspection ready.

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

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

Global and US Recall / Market Withdrawal

• Supports the coordination of the execution activities related to US product recall and withdrawals.
• Participate in periodic product withdrawal/recall simulations.
• Consult and train local recall coordinators to assure understanding of process for product removal.
• Monitors 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: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies 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 product, such as importers, agent, and function.
• Update drug and device establishment registrations for changes as required including completion of annual registrations.

US Volume Reporting

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

Personal Development and Shared Learning

• Be continually aware of current industry trends and regulatory agency interpretation 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 which 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 function
• Strong compliance knowledge
• Excellent communication and presentation skills: ability to deliver constructive feedback
• Skilled 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 tends; ensure corporate standards remain current.
• Flexibility to effectively prioritize work activities to meet regulated timelines.
• Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
• Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs).
• Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements may change over time and may include additional responsibilities not specifically described in the job description.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$126,000 - $204,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.