Lilly is a global healthcare leader committed to making life better for people around the world. Our employees work together to discover and bring life-changing medicines to those who need them, improve disease understanding and management, and give back to our communities through philanthropy and volunteerism.
We are seeking a Global Clinical Regulatory Associate to join our team in Indianapolis, Indiana. This role will be responsible for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients.
Key Responsibilities:
* Provide regulatory and drug development expertise to support electronic submission regulations and guidance.
* Lead the registration management process by partnering with other geographies to understand and incorporate local agency regulations and requirements.
* Guide development teams and functions on internal and Agency registration management processes and requirements.
* Own the registration management process at the molecule/project level to ensure timely, complete, and accurate electronic records.
* Serve as the operational lead for registration planning and execution.
* Own routine compliance submissions and processes.
* Partner with the Regulatory Coordinator/Scientist to drive product deletion and withdrawal processes.
* Provide registration management expertise to due diligence and business development processes.
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.
* Effective written, spoken, and presentation skills.
* Effective negotiation and influence skills.
* Attention to detail.
* Effective teamwork skills.
The estimated salary for this role is $80,000 - $110,000 per year, depending on experience and qualifications. We offer a competitive benefits package, including health insurance, retirement savings plan, and paid time off.