Offer type: full time
Location: Illinois - Lake County
Regulatory Affairs continually strives to design and deliver optimized regulatory strategies and tactical plans that align with overall business goals.
The Associate Director/Director – US & Canada Regulatory Affairs is a key role for an individual with a strong technical or scientific background who has demonstrated skills and knowledge in areas such as, but not limited to: strategy development; risk assessment and mitigation; and monitoring and communicating key events in the external environment with potential to impact projects. Additionally, the ideal candidate should have a proven track record of success working in a matrix environment and experience negotiating regulatory strategies for products with FDA and Health Canada.
Key responsibilities include, but are not limited to:
•Develop and implement robust US and Canadian regulatory strategies to support projects from phase 1 through postmarketing lifecycle management
•Review, compile, and submit new clinical development and marketing applications, supplements and amendments, as well as responses to Health Authorities as needed
•Provide leadership to assigned teams
•Independently manage complex issues and projects with minimal supervision
•Ensure regulatory commitments and timelines are met for assigned projects
•Provide guidance on project decisions and make recommendations for improvements
•Serve as liaison with FDA, and lead pre-IND, end-of-phase II, pre-NDA, and all other relevant interactions/communications with FDA
•Develop collegial, mutually productive relationships with the FDA and internally
•Steers projects and communicates to manager any issues that would result in a delay
•Effectively negotiate regulatory agreements with Health Authorities