Pursuant to 21CFR207.69 the successful candidate would act as the Firm’s “official contact and United States Agent” before the Food and Drug Administration.
The primary focus of the Agent, in addition to those defined under Part 207, would be to advise the Firm on all regulatory matters developing in the areas of Drug Master Files, FDA Site inspections, and interactions with its NDA Sponsor. The individual must possess a thorough and complete knowledge of FDA’s Q7 Guideline along with its related guidelines.
The Agents ultimate purpose is to advise the Firm on how to maintain a posture of compliance with FDA Regulations/Guidelines, and to advise it properly when the Firm’s posture is challenged.
The individual will resides in US but must have the ability to travel to Europe on a reasonably short notice, if requested.
The candidate must possess at least a Bachelor’s Degree in Science, preferably Chemistry.
- 15 years of experience in the pharmaceutical industry,
- 10 or more of these years in a Regulatory Affairs managerial capacity, with
a major portion of this time focused on GMPs and interaction with FDA
- 3 or more years of experience working with international firms
addressing FDA regulations and guidelines
The candidate must possess excellent English communication skills