Vice President of Regulatory Affairs - Biologics
Statewide, CA US
Respected 10+ year old Biologics company with strong growth, excellent compensation, and equity potential!
As the VP of RA, you will define strategies for, coordinate the execution of, and ensure the proper archival of regulatory submissions including clinical trial applications; Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA) and Marketing Authorization Approvals (MAAs) for a leading biologic company experiencing monumental growth.
- Develop strategies for the regulatory approval of existing and new medical devices including resource requirements.
- Interact with the FDA, Notified Bodies, Authorized Representatives and Competent Authorities for maintaining and managing the Device Registrations, Compliance Inspections, Remediation, Field Actions, MDR and Vigilance Reporting processes
- Determine regulatory status of existing and new devices, as well as requirements for their approvals
- 15+ years of industry experience in Regulatory Affairs for biological products in product development and post licensure settings.
- Direct experience with FDA and international agencies required.
- Solid understanding of dossier requirements, Biologics License (BLA) Applications, New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (CTA).
Compensation: Aggressive; Commensurate to Experience
Direct Reports: Yes
Years of Experience: 15+
Degree: PhD or other advanced degree strongly preferred
Born and raised in Central Florida, Carolyn is a true Orlando native, graduating from Winter Park High School and the University of Central Florida (Go Knights!) Prior to Legacy, she put her Human Resources Management degree to good use, spending nearly 15 years in a Human Resources Generalist role for a mid-sized manufacturing company.