Manages individual regulatory projects, including the preparation of correspondence and submission components to the FDA and other regulatory authorities. Works closely with Regulatory Operations staff to ensure applications, amendments, and supplements are submitted in accordance with U.S. Regulations and Guidelines. Acts as direct liaison with FDA to facilitate the review and approval of applications under the direction of client and/or the Management of Regulatory Affairs.
PRIMARY JOB FUNCTIONS:
Prepares and executes regulatory strategy for assigned projects
Provides advice and counsel to internal and client project teams/management on issues related to regulations and regulatory applications
Prepares high quality submission components and/or reviews components prepared by other contributors, prior to submission to the FDA.
Serves as primary interface with FDA for sponsors for assigned submissions, including written communication, teleconferences and face-to-face meetings.
Works closely with regulatory operations staff to ensure all applications are submitted in accordance with U.S. Regulations and Guidelines
Represents Premier Research and the sponsor in interactions with the FDA on assigned projects
Maintains accurate records of all agency interactions.
Assists Regulatory Management in any aspects related to the support of projects assigned to PRG Regulatory Affairs.
Maintains up-to-date knowledge base for all pertinent US and International regulations.
All other projects as assigned
Good computer and presentation skills
Detail-oriented and well organized
Excellent verbal and written communication skills
Ability to perform business travel, less than 20%
Bachelor's Degree in a scientific discipline is required, with PharmD or PhD preferred
Minimum of five years experience in regulatory affairs, medical affairs or clinical research, at least three of which must be specifically in some area of regulatory affairs
Demonstrated knowledge of U.S. regulations is required, knowledge in international regulations is desirable
Knowledge of the drug development process and project team environment is required
Fluent in spoken and written English