Job Title
This role is an exciting opportunity for a skilled professional to join our dynamic team as a Regulatory Affairs Professional. As a key member of the regulatory affairs function, you will be responsible for developing and executing regulatory strategies that align with business objectives.
About the Role
We are seeking an experienced Regulatory Affairs Specialist who has a strong understanding of FDA and Health Canada procedures and practices across Review Divisions. You will be responsible for leading the development of regulatory strategies, reviewing and summarizing information regarding regulator expectations, and communicating these insights to internal stakeholders.
The ideal candidate will have a proven track record of success in regulatory affairs, including experience with IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo submissions. Strong written and verbal communication skills are essential, as well as the ability to negotiate and influence effectively within a highly regulated environment.
Key Responsibilities
* Develop and execute US and Canada registration strategy
* Initiate and update Regulatory Strategy Document
* Leverage scientific, drug/device clinical development, and knowledge from FDA/HC meetings and regulatory trends
* Integrate information from external environment, product-specific regulator advice, and other public information (i.e., Advisory Committees) to develop robust, innovative regulatory strategies
* Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labeling
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
Benefits
* Competitive salary and benefits package
* Opportunities for career growth and professional development
* Collaborative and dynamic work environment
Others
Lilly is an equal opportunities employer and welcomes applications from diverse candidates.