Responsible for US regulatory affairs strategy for assigned projects covering the development, registration and post approval phases, and acts as liaison with the health authorities including the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER); Center for Biologic Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) and Office of Generic Drugs (OGD) review divisions. Works closely with other functional areas to develop and lead achievement of regulatory strategies, operations, clinical and product development as well as pharmacovigilance.
***MUST RELOCATE TO THE PHILADELPHIA AREA***
Ideal skillset and responsibilities:
- Plans, coordinates and leads meetings with Regulatory Authorities (e.g., Pre-IND, End of Phase 2, Pre-NDA, QSubmissions, IDE) including meeting requests, meeting background documents and action plan following such meetings
- Strong experience in clinical operations, research and related US regulatory experience
- Primary contact and liaison with key personnel in FDA review divisions for assigned projects
- Demonstrated ability to champion and negotiate sponsor positions and proposals
- Oversight of scientific product information including clinical development and related regulatory strategies for drugs, biologics, generics and devices. Provides advice and direction for identifying and assessing clinical and regulatory risks regarding Agency requirements and strategies
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 29 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.