Regulatory Affairs Manager

JOB DESCRIPTION

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

Regulatory Planning

Dossier Management

Regulatory Compliance

Labelling

Process Improvement

Minimum Qualification Requirements :

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 (

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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