Senior Director, Regulatory Affairs

Scorpion Therapeutics; Radnor (Delaware County); On-site; USD 210,000 - 320,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for biologics with a focus on late-stage development. You will manage IND/CTA, BLA/sBLA, and MAA submissions, oversee FDA, EMA, and MHRA interactions, and guide cross-functional teams in a fast-paced environment.

The role requires an advanced degree and 8–15 years in drug regulation, with proven leadership and mentoring abilities.

Qualifications

• Advanced degree required (MS/PharmD/Ph.D./MD).
• 8–15 years' experience in drug regulation.

Responsibilities

• Develop and execute regulatory scientific and tactical plans.
• Manage IND/CTA, BLA/sBLA, and MAA submissions.
• Oversee agency interactions including FDA, EMA, and MHRA.
• Lead cross-functional teams and provide regulatory guidance.
• Mentor direct reports.

Skills

Regulatory strategy

IND/CTA/BLA submissions

FDA interactions

Leadership

Mentoring

Education

Advanced degree (MS/PharmD/Ph.D./MD)

Job description

Role:

Senior Director of Regulatory Affairs responsible for leading global regulatory strategies and submissions for biologics development programs, with a focus on late-stage development.

Responsibilities:

develop and execute regulatory scientific and tactical plans, manage IND/CTA, BLA/sBLA, MAA submissions, oversee agency interactions including FDA, EMA, and MHRA, and ensure compliance with global regulatory requirements. Lead cross-functional teams, provide regulatory guidance, and mentor direct reports.

Requirements:

advanced degree (MS, PharmD, Ph.D., or MD) with 8-15 years' experience in drug regulation, strong expertise in biologics, extensive US regulatory submission experience, and proven leadership skills.

HighValue:

biologics, late-stage development, IND/BLA filings, global regulatory strategy, FDA interactions, leadership in regulatory sciences, experience supporting clinical studies and preparing for health authority meetings.

WorkSetup:

roles based in Gaithersburg, MD or Radnor, PA, with a high-profile, fast-paced environment requiring agility and strategic influence.