Regulatory Affairs Director

Scorpion Therapeutics; Aliso Viejo (CA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager, Regulatory Affairs to drive global regulatory strategies for drug/device combination products and pharmaceuticals. You will lead IND/NDA/CTA submissions and interactions with FDA, EMA, and other authorities, aligning across cross-functional teams.

The role is hybrid in Aliso Viejo, CA, offering leadership mentorship, staying current with global regulatory trends, and guiding junior staff to ensure compliant, timely submissions.

Qualifications

• Bachelor’s degree in science or related field.
• 9+ years in life sciences with 6+ years in regulatory affairs for pharmaceuticals and combination products.
• Experience with IND/NDA submissions and agency interactions.
• Knowledge of FDA/ICH, EU regulations, GxPs

Responsibilities

• Develop and implement regulatory plans.
• Prepare and oversee submissions including INDs, NDAs, and CTAs.
• Lead interactions with FDA, EMA, and other authorities.
• Ensure regulatory compliance across cross-functional teams.
• Mentor junior staff.
• Stay current with global regulatory trends.

Skills

Communication

Project management

Leadership

Education

Bachelor’s in science

MS

PharmD

PhD

RAC certification

Job description

Senior Manager, Regulatory Affairs

leading global regulatory strategies for drug/device combination products and pharmaceuticals.

Responsibilities

• develop and implement regulatory plans
• prepare and oversee high-quality submissions including INDs, NDAs, and CTAs
• lead interactions with FDA, EMA, and other authorities
• ensure regulatory compliance and alignment across cross-functional teams
• mentor junior staff
• stay current with global regulatory trends

Requirements

• Bachelor’s in science
• 9+ years in life sciences, with 6+ years focused on regulatory affairs for pharmaceuticals and combination products
• experience in IND/ NDA submissions and agency interactions
• knowledge of FDA/ICH, EU regulations, GxPs
• strong communication, project management, and leadership skills

Preferred

• MS
• PharmD
• PhD
• RAC certification

High Value

• experience with combination products
• global regulatory strategy
• IND/ NDA preparation
• FDA/EMA engagement

WorkSetup: hybrid Aliso Viejo, CA.