Oversees all regulatory operations and strategic aspects of assigned products, including the preparation and submission of correspondence and applications to regulatory agencies. Acts as direct liaison (U.S. Agent) with FDA to facilitate the prompt review and approval of applications under the direction of client. Provides strategic input on client’s development plans in line with US and/or international Regulations and Guidances. Has particular experience with Oncology programs.
PRIMARY JOB FUNCTIONS:
Provides comprehensive regulatory services, advice and counsel to project teams.
Directs, assists, and executes the production of high quality written deliverables, including INDs, IND correspondence, agency meeting packages and minutes, NDAs, 510Ks, PLAs, or BLAs
Represents Premier Research and sponsor (client) in all interactions with the FDA
Develops proactive regulatory strategies for client
Maintains up-to-date knowledge base for all pertinent US and International regulations
Assists Business Development, as needed, in their efforts to seek and secure new, and further ongoing, business related to the regulatory affairs department
All other projects as assigned
Ability to perform business travel, less than 20%
Minimum of a Bachelor's Degree in a scientific discipline (PharmD or MS preferred)
Minimum of eight years experience in regulatory affairs, medical affairs or clinical research, at least five of which must be specifically in some area of regulatory affairs
Experience in Oncology programs, either in a regulatory or clinical environment.
Demonstrated in-depth knowledge of US and international regulations
Project team environment experience
Excellent computer and presentation skills
Proven track record in people/team building skills
Detail-oriented and well organized
Excellent verbal and written communication skills