At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader with headquarters 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.
We are looking for a Regulatory Affairs Specialist who will develop, update and execute US and Canada registration strategy. This includes assisting or leading in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends.
Responsibilities
1. Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends.
2. Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.
3. Monitor upcoming and recent approvals of competitive development programs/plans.
4. Integrate US/CA regulatory strategy into global registration strategy.
5. Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy.
6. Communicate and share key information to enable seamless execution of US/Canada regulatory strategy.
This role requires strong communication and negotiation skills, as well as the ability to assess and manage risk in a highly regulated environment.
Requirements
* Bachelor's degree in scientific or health sciences discipline.
* Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years.
* Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable.
Lilly is an equal opportunity employer and welcomes applications from diverse candidates.