Regulatory Affairs Director

Job Summary

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

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 and ensure effective regulatory agency communications

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
• Ability to lead and build effective teams
• Experience in developing registration strategies and plans
• Strong understanding of global regulatory requirements and guidance
• Experience in managing multiple activities and making complex decisions