Description
I am currently looking for a REGULATORY AFFAIRS MANAGER for a 6 month CONTRACT position to help an expanding company bring their drug development process and operations in-house.REGULATORY AFFAIRS MANAGER- CONTRACT
6 MONTHS
COMPETITIVE RATES
BOSTON
REGULATORY AFFAIRS MANAGER- CONTRACT
Responsibilities are but not limited to:
-Documentation & Coordination
-Support of clinical programs for regulatory documentation and filings
-NDAs INDs MAAa
TRANSITION FROM PAPER TO ELECTRONIC
-formatting, data entry, maintain regulatory SOPs
-ensure consistency across documentation platforms
Qualifications/Requirements:
-BS in Life Sciences, Related field
-Minimum 3+ years in Regulatory, specifically in clinical trial applications
-Thorough knowledge of drug development process
-ELECTRONIC SUBMISSIONS EXPERIENCE