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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

This role is responsible for regulatory reporting activities and market actions including reporting of US FDA field alerts, biological product deviation reports, illegitimate product, global regulatory reporting, oversight of global recall and US recall activities, update drug and device establishment registrations for changes as required including completion of annual changes. This role is also responsible for gathering and analyzing information for inspections, annual product reviews, periodic reviews, site compliance reports, as needed.

Responsibilities:

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

• Coordinate and execute regulatory Reporting: Includes networking with CPQA, Global Quality Leaders, Senior Management, Legal, Global Patient Safety, Technical Services, Regulatory, Product Protection team, Lilly Security and others as appropriate to determine the need and document the decision for regulatory reporting. Generate, submit and maintain documentation following standard.
• Serve as Subject Matter Expert for global standard.
• Provide information for use in various periodic reviews or metrics.

Global and US Recall / Market Withdrawal

• Provides oversight and support to Local Recall Coordinators in executing product returns resulting from recalls and withdrawals according to GQS131, Recalls and LQS135, Market Withdrawal. Maintain documentation resulting from global recall.
• Serve as Subject Matter Expert for global standard and local procedure.
• Provide information for use in various periodic reviews or metrics.
• Coordinate 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.

Drug and Device Establishment Registration

• Determine information required for drug listing 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 changes.
• Maintain GQAAC SOPs for drug and device establishment registrations.

Site Compliance Report

• May participate to the gathering and analyzing information such as complaints, deviations, audit and inspection history, notification to management, and annual product reviews to provide an independent assessment of the state of compliance at Lilly sites or contract organizations.

Basic Requirements:

• Bachelor's degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences
• Minimum of 10 years relevant industry experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs

Additional Preferences:

• Prior experience interacting/communicating with the US FDA and/or other global regulatory agencies regarding regulatory reporting
• Broad knowledge of GMPs and quality systems as they apply to pharmaceutical manufacturing and marketing
• Maintain awareness of regulatory and industry tends; ensure corporate standards remain current
• Flexibility to effectively prioritize work activities to meet regulated timelines
• Demonstrated strong oral and written communication and interpersonal interaction skills, with interaction at multiple levels of the companies.
• Ability to work across functional areas with people at all levels of the organization;
• Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management;
• Organized with attention to detail;
• Multi-tasking and self-management to meet multiple overlapping timelines
• Proficient in global IT tools such as TrackWise, Regulus, SharePoint

Additional Information:

• Limited travel for training or conferences

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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