Sr. Director, Regualtory Affairs

• 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.
  

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