Senior Director Regulatory Affairs

Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. This role will lead the North America regulatory strategy and work extremely closely with the C-Suite leaders of the business. They are focused on Autoimmune diseases and are based in New Jersey. This is a hybrid role with 3 days per week in office.

Responsibilities:

• Launch the company's regulatory strategy having leadership over all regulatory activities
• Oversee product registration and submission
• Ensure compliance with FDA
• Work closely with CROs and manage relationships
• Provide Operational Leadership

Qualifications:

• 10+ years of Regulatory Affairs experience
• Strong Regulatory Operations experience, specifically eCTD submissions
• Broad knowledge of CMC, Quality and Quality Operations
• Early stage experience preferred
• Bachelor’s degree required, advanced degree preferred