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.

Manage regulatory operational and technical aspects on company’s behalf for the business partners who are marketing authorization holders:

Align on submission plans, monitor progress and provide support as necessaryEnsure timely provision of required submission dossiers to business partnersFoster an environment of operational excellence and liaise cross-functionally on regulatory strategyOversee labelling projects to ensure new and revised labelling are implemented timely

Partner Collaboration and Oversight

Build and maintain strong working relationships with business partnersFollow-up on application progress and periodically review business partner performance metricsServe as regulatory point person for any regulatory queries from internal and external stakeholdersEnsure business contracts are current and validResponsible for the execution of third party management activitiesCoach Regulatory Associates on third party oversight and establish metrics

Regulatory Planning 

Collaborate with business partners to ensure timely and clear dossier requirements during submission planningLiaise cross-functionally with internal and external stakeholders to agree on regulatory strategyFacilitate implementation of the regulatory plan

           

Dossier Management

Obtain all required submission documents and ensure timely responses to Regulatory Authority requestsEnsure documents meet requirements or use regulatory expertise to provide creative solutions if unable to meet requirementsEnsure provision of submission documents to business partner per contract timelinesEnsure archiving of electronic copies of applications

Regulatory Compliance

Ensure data maintenance and data integrity of regulatory systems with defined compliance metricsEnsure implementation of local quality system in line with the global quality systemEnsure audit and inspections readinessEffective issue management and implement corrective/preventive actions as appropriate

Labelling

Perform the role of a labelling responsible personEnsuring that product information complies with company core data sheetLiase with Supply Chain to ensure timely implementation of label changes

Process Improvement

Ensure alignment and implementation of internal regulatory initiatives

Minimum Qualification Requirements:

Bachelor's degree or equivalent in a relevant scientific subjectAt least one year industry related experience in Regulatory AffairsTeam working skills with special focus on resultsAbility to adapt to challenging situationsDemonstrated good computer/IT skillsGood knowledge of written and spoken EnglishAnalytical, problem solving and negotiation skillsGood communication skillsProject management skillsStrong knowledge of quality systems

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 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.

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