Strategic Global Regulatory Lead

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation

Medical/dental/vision/prescription

Well-being benefits

Job summary

Scorpion Therapeutics in Indianapolis seeks a Global Regulatory Lead to shape global regulatory strategies from early development through lifecycle. You will lead a cross-functional regulatory team, interact with the US FDA, and ensure alignment with global brand strategies and regulatory submissions.

This senior role requires strong leadership, strategic thinking, and outstanding regulatory science expertise. You will mentor regulatory personnel and drive alignment with corporate goals.

Qualifications

• Advanced scientific degree (PharmD, PhD) and 8+ years in regulatory affairs and/or drug development.
• OR
• Bachelor’s or Masters and 10+ years in regulatory affairs and/or drug development
• Global regulatory procedures knowledge; experience across US, EU, China, Japan
• Clinical and CMC regulatory science experience

Responsibilities

• Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle
• Lead regulatory representation on the GBD/global program team; shape development plans and address regulatory barriers
• Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
• Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs)
• Drive high-quality communications with FDA articulating scientific position
• Build relationships with FDA to support product registration goals
• Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
• Foster transparent communication, feedback, and continuous development
• Represent GRA at stakeholder/governance meetings; mentor GRA personnel
• Build external stakeholder relationships; advise promotional strategy and review press/IR materials

Skills

Leadership

Executive communication

Regulatory strategy

Cross-functional collaboration

Education

PharmD

PhD

Bachelor's degree

Master's degree

Job description

Scorpion Therapeutics in Indianapolis seeks a Global Regulatory Lead to shape global regulatory strategies from early development through lifecycle. You will lead a cross-functional regulatory team, interact with the US FDA, and ensure alignment with global brand strategies and regulatory submissions.

This senior role requires strong leadership, strategic thinking, and outstanding regulatory science expertise. You will mentor regulatory personnel and drive alignment with corporate goals.