Job Details
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