Location: Florham Park,NJ, USA
JOB DESCRIPTION
Insight Global is seeking an Associate Director of Regulatory Affairs to join the one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for developing and executing regional regulatory strategies for antiviral products. It is essential that this person has experience working with therapeutics and possesses a strong knowledge of regulatory requirements for Phase 1, 2, and 3. Additionally, excellent communication is necessary as this person will interact with regulatory authorities on a consistent basis. This starts as a 12-month contract and requires to be in office 50% of the time. This position has no direct reports.
REQUIRED SKILLS AND EXPERIENCE
• 7+ years of experience with regulatory strategy in the US
• Background heavily focused on therapeutics
• Knowledge of Phase 1, 2, and 3 regulatory requirements
• Experience fostering and maintaining relationships with regulatory authorities (FDA, ICH, etc.)
• Bachelor's degree in life science, pharmacy, bioscience, or a related discipline
NICE TO HAVE SKILLS AND EXPERIENCE
• Master's or PhD in a relevant scientific field
• Experience with antiviral products
• Experience with IND and NDA submissions