Regulatory Affairs Director

Job Summary

Leading the Global Regulatory Team in a remote full-time capacity, the Regulatory Affairs Director will develop and execute global regulatory strategies for products in the Inflammation and Rare Disease Therapeutic Area, ensuring effective regulatory agency interactions and compliance throughout the product lifecycle.

Key responsibilities:

• Develop and execute the global regulatory product strategy
• Lead Global Regulatory Teams and represent Regulatory on product teams
• Plan and implement global regulatory filings to achieve product approvals and maintain compliance

Required qualifications:

• Doctorate degree with 4 years, Master's degree with 7 years, or Bachelor's degree with 9 years of regulatory experience in biotech or science
• Proven ability to lead and build effective teams
• Experience in developing regulatory strategies and managing complex regulatory submissions
• Strong understanding of global regulatory requirements and agency interactions
• Ability to anticipate and mitigate strategic issues in a regulatory context