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Job Title: ASSOCIATE DIRECTOR/DIRECTOR, REGULATORY AFFAIRS (US & Canada) NEW ( ID: A1921 )
Career Category: Compliance, In-house Counsel, Pharmaceutical, Regulatory
Posted Date: 2015-09-22
Location: Illinois, U.S.A.
Description:  
Do you have a unique background combining law and science? Life After Law has the right opportunity for you!

Our client, a leading biopharmaceutical company, is seeking and Associate Director/Director – US & Canada Regulatory Affairs for their Lake County, Illinois office. The role is a great fit 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:
•Develop and implement robust US and Canadian regulatory strategies to support projects from phase 1 through post marketing 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

Requirements:

•Bachelor's degree in science
•5-10 years of experience in the biopharmaceutical industry
•Advanced degree (PhD or PharmD) preferred
•5-10 years of experience in US regulatory affairs preferred
•4-5 years in experience in women/men's health/Cardiovascular preferred

If you are interested in this exciting opportunity and possess the aforementioned skills and experience, please submit your resume online. Only those with the required experience will be contacted. Thank you.

Judy Kremer
National Manager
(866) 227-1444 x 225
jkremer@lifeafterlaw.com

        

 

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