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 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 Role
We are seeking a highly skilled Global Clinical Regulatory Associate to join our team in Global Regulatory Affairs (GRA) Regulatory Delivery & Excellence (RD&E). In this role, you will be accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients.
Key Responsibilities:
Registration Management Expertise
* Provide regulatory and drug development expertise to support the registration management process.
* Lead the registration management process by providing expertise in electronic submission regulations and guidance.
* Partner with other geographies to understand and incorporate local agency regulations and requirements.
* Guide and influence development teams regarding internal and Agency registration management processes and requirements.
Leadership and Collaboration
* Develop collaborative relationships with personnel in other Lilly functional areas.
* Create an environment within the team and GRA that encourages open discussions on issues.
* Partner with the Regulatory Scientist to plan, facilitate, and document internal, FDA, and partner meetings.
* Leverage internal and external forums to continue to develop and share regulatory expertise.
Requirements
* Bachelor's degree or higher in a technical discipline such as chemistry, biology, pharmacy, or equivalent demonstrated industry experience.
* Knowledge of the drug development process.
Preferred Qualifications
* Quick learning agility, retention of knowledge, strong project management skills.
* Previous project management and global submission experience.
* Demonstrated ability to operate and manage operational requirements in a highly regulated environment.
* Demonstrated effective written, spoken, and presentation skills.