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.
We 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.
Purpose
The Global Clinical Regulatory Associate supports the expedited delivery of safe and effective products to patients by managing operational and technical registration processes.
Key Responsibilities:
* Provide regulatory expertise in electronic submission regulations and guidance.
* Lead registration management process and partner with geographies to incorporate local agency regulations and requirements.
* Guide development teams on internal and Agency registration management processes and requirements.
* Own molecule/project-level registration management to ensure timely, complete, and accurate records.
* Serve as operational lead for registration planning and execution.
* Manage routine compliance submissions and processes.
Collaboration and Influence:
* Develop relationships with personnel in other Lilly functional areas.
* Create an environment that encourages open discussions on issues.
* Partner with the FDA Office of Business Informatics (OBI) to develop regulatory expertise.
* Influence others to create maximum advantage for the organization.
Requirements:
* BS or higher degree in a technical discipline such as chemistry, biology, pharmacy, or equivalent demonstrated industry experience.
* Knowledge of drug development process.
Additional Preferences:
* Quick learning agility and strong project management skills.
* Previous project management and global submission experience.
* Effective written, spoken, and presentation skills.
* Effective negotiation and influence skills.