Director, Regulatory Strategy – Global Regulatory Lead

Location: Hybrid in Boston, Massachusetts, United States; minimum of two on-site days per week, currently Tuesday and Wednesday.

Salary: $211,500–$258,500 USD annually, plus potential discretionary bonus and long-term incentive award.

Company

Clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Develop and lead integrated global regulatory strategies for early-stage and pipeline programs in immunology and inflammation.
• Serve as the primary regulatory strategist for lupus and adjacent autoimmune indications.
• Lead Health Authority relationships from pre-IND through Phase II clinical programs.
• Guide development teams in regulatory-sound plans, filing strategies, and early Health Authority engagement.
• Provide a global regulatory perspective across FDA, EMA, and other major jurisdictions.
• Help build regulatory infrastructure, capabilities, and organizational best practices for pipeline oversight.

Requirements

• Experience developing global regulatory strategies for early clinical and translational programs.
• Experience with pre-IND through Phase II development and Health Authority interactions.
• Ability to guide cross-functional teams on regulatory development plans and filing strategies.
• Experience working across FDA, EMA, and other major regulatory jurisdictions.
• Advanced education, such as a master’s degree or MBA, is listed for the position.
• Availability for the required hybrid schedule in Boston, with at least two on-site days per week.

Culture & Benefits

• Comprehensive benefits package tailored to the hiring country and region.
• Potential discretionary annual bonus based on individual and company performance.
• Potential long-term incentive award, including equity.
• Inclusive workplace committed to equal employment opportunity and reasonable accommodations.