Strategic Regulatory Affairs Director – Global Submissions

Latigo Biotherapeutics, Inc.; Thousand Oaks (CA); Hybrid; USD 210,000 - 280,000; Full time

Job summary

Latigo Biotherapeutics, Inc. is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy and execution for development programs, ensuring global health authority compliance (FDA, EMA, and other agencies).

You will shape regulatory plans, oversee submissions (INDs, CTAs, NDAs), and guide cross-functional teams to align on development timelines. The role requires strong experience with FDA interactions, CMC and clinical development processes, and the ability to manage regulatory

Qualifications

• Minimum 8 years of regulatory experience.
• Direct experience leading or supporting FDA interactions.
• Experience with IND submissions and maintenance.
• Knowledge of US procedures and EU CTA/MAA is preferred.

Responsibilities

• Lead regulatory strategies to support product development.
• Manage IND/CTAs/NDAs submissions and documents.
• Coordinate regulatory interactions with FDA and global authorities.
• Collaborate with Clinical, CMC, QA to integrate regulatory input.

Skills

Regulatory leadership

FDA interactions

IND submissions

Regulatory strategy

Cross-functional collaboration

Attention to detail

Excellent communication

Education

Bachelor's in life sciences

Master's in life sciences

PhD

PharmD

Job description

Latigo Biotherapeutics, Inc. is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy and execution for development programs, ensuring global health authority compliance (FDA, EMA, and other agencies).

You will shape regulatory plans, oversee submissions (INDs, CTAs, NDAs), and guide cross-functional teams to align on development timelines. The role requires strong experience with FDA interactions, CMC and clinical development processes, and the ability to manage regulatory