Global Regulatory Lead - Strategy & FDA Submissions

Scorpion Therapeutics; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits package

Job summary

Scorpion Therapeutics seeks a Global Regulatory Lead to own global regulatory strategies from entry to lifecycle, providing strategic and technical leadership to a cross-functional team and serving as the primary regulatory voice with the US FDA.

The role includes overseeing US FDA submissions (INDs/NDAs/BLAs), shaping development plans, and aligning global regulatory plans with local affiliates. Travel is 10–15%, relocation support available.

Qualifications

• Advanced degree and 8+ years in regulatory affairs and/or drug development.
• Or 10+ years with a Bachelor’s/Master’s.
• Global regulatory knowledge and leadership experience.

Responsibilities

• Develop and execute global regulatory strategies across US/EU/Asia.
• Oversee US FDA submissions and interactions (INDs, NDAs, BLAs).
• Lead a cross-functional Global Regulatory Team and mentor staff.
• Coordinate alignment of local affiliate regulatory plans with global strategy.

Skills

Leadership

Negotiation

Stakeholder communication

Regulatory strategy

Education

PharmD/PhD

Bachelor's or Master’s

Job description

Scorpion Therapeutics seeks a Global Regulatory Lead to own global regulatory strategies from entry to lifecycle, providing strategic and technical leadership to a cross-functional team and serving as the primary regulatory voice with the US FDA.

The role includes overseeing US FDA submissions (INDs/NDAs/BLAs), shaping development plans, and aligning global regulatory plans with local affiliates. Travel is 10–15%, relocation support available.