Regulatory Affairs Manager

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 necessary

Ensure timely provision of required submission dossiers to business partners

Foster an environment of operational excellence and liaise cross-functionally on regulatory strategy

Oversee labelling projects to ensure new and updated labelling are implemented timely

Business Partner Collaboration and Oversight

Build and maintain strong working relationships with business partners

Follow-up on application progress and periodically review business partner performance metrics

Serve as regulatory point person for any regulatory queries from internal and external stakeholders

Ensure business contracts are current and valid

Responsible for the execution of third party management activities

Coach Regulatory Associates on third party oversight and establish metrics

Regulatory Planning

Collaborate with business partners to ensure timely and clear dossier requirements during submission planning

Liaise cross-functionally with internal and external stakeholders to agree on regulatory strategy

Facilitate implementation of the regulatory plan

Dossier Management

Obtain all required submission documents and ensure timely responses to Regulatory Authority requests

Ensure documents meet requirements or use regulatory expertise to provide creative solutions if unable to meet requirements

Ensure provision of submission documents to business partner per contract timelines

Ensure archiving of electronic copies of applications

Regulatory Compliance

Ensure data maintenance and data integrity of regulatory systems with defined compliance metrics

Ensure implementation of local quality system in line with the global quality system

Ensure audit and inspections readiness

Effective issue management and implement corrective/preventive actions as appropriate

Labelling

Perform the role of a labelling responsible person

Ensuring that product information complies with company core data sheet

Liase with stakeholders 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 subject

Team working skills with special focus on results

Ability to adapt to challenging situations

Demonstrated good computer/IT skills

Good knowledge of written and spoken English

Analytical, problem solving and negotiation skills

Good communication skills

Project management skills

Strong 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 ( 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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