Global Regulatory Lead: Drug Development & FDA Strategy

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Global Regulatory Lead (GRL) to develop and execute global regulatory strategies across the product lifecycle. You will provide strategic and technical leadership to a cross-functional team and manage US FDA interactions to accelerate development and approvals.

The role requires a strong background in regulatory affairs, INDs/NDAs/BLAs, and a track record of shaping regulatory plans that align with global objectives. Based in Indianapolis, IN with travel.

Qualifications

• Bachelor's degree with 8+ years in regulatory affairs or drug development.
• Advanced scientific degree preferred.

Responsibilities

• Shape regulatory strategies for development, approval, and post-market phases.
• Oversee US FDA submissions (INDs, NDAs, BLAs).
• Ensure regulatory plans align globally and locally.
• Represent regulatory interests in cross-functional teams.
• Build external stakeholder relationships.

Skills

Regulatory strategy

US FDA interactions

Cross-functional leadership

Global regulatory submissions

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Scorpion Therapeutics is seeking a Global Regulatory Lead (GRL) to develop and execute global regulatory strategies across the product lifecycle. You will provide strategic and technical leadership to a cross-functional team and manage US FDA interactions to accelerate development and approvals.

The role requires a strong background in regulatory affairs, INDs/NDAs/BLAs, and a track record of shaping regulatory plans that align with global objectives. Based in Indianapolis, IN with travel.