Leadership of the QA, Regulatory Affairs and Compliance functions.
Generate the preparation of submissions to obtain and maintain approvals for commercially distributing products within the US.
Provide leadership and activities to ensure compliance with U.S. regulatory requirements.
The key to this role will be a deep understanding of the US Food and Drug Administration (FDA), regulatory processes and expectations.
This is an individual contributor role.
Small company experience is ideal.
Experience negotiating / communicating with FDA
Experience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.
This role is Hybrid in New Jersey in Somerset county (No remote candidates will be considered) Minimum 1-3 days onsite per week.