Executive Director of Regulatory Affairs

Job Summary

Leading global regulatory strategies for oncology products, the full-time Executive Director of Regulatory Affairs will develop and implement strategies for IND/CTA approvals and subsequent marketing applications while working remotely.

Key responsibilities

• Lead global regulatory strategies for assigned products through all development phases, including approvals and post-marketing efforts
• Represent Regulatory Affairs in development collaborations and partnerships, including leading due diligence for business development activities
• Advise management and cross-functional teams on relevant laws, regulations, and standards affecting regulatory policies and strategies

Required qualifications

• Bachelor's degree in life sciences; Master's or Doctorate preferred
• Minimum of 15+ years of experience in pharmaceutical/biotech regulatory activities, with leadership experience in multiple major regions
• Significant experience with marketing/license applications (e.g., BLA, NDA, MAA) and supporting product launch activities
• Minimum of 10+ years in a strategic leadership role with strong project management skills
• Experience interfacing with major government regulatory authorities and strong negotiation skills