Director, Regulatory Affairs — Global Submissions Lead

Latigo Bio; Thousand Oaks (CA); On-site; USD 170,000 - 230,000; Full time

Job summary

Latigo Bio is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across development programs. The role supports FDA/EMA interactions, IND submissions, and device-to-market planning, coordinating with Clinical Development, CMC, Nonclinical, and Quality teams.

You will ensure compliance with global regulations, manage regulatory vendors, and guide cross-functional teams through development to commercialization, with a focus on fast-to-market initiatives and robust

Qualifications

• Bachelor’s, Master’s, PharmD or PhD in life sciences.
• Minimum of 8 years of regulatory experience.
• Experience leading or supporting FDA interactions.
• US registration experience preferred.
• Experience with IND submissions and maintenance.
• Knowledge of US procedures (fast-to-market a plus).
• Familiarity with EU CTA/MAA regulatory processes preferred.
• Regulatory project management experience preferred.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Attention to detail essential.

Responsibilities

• Lead regulatory strategies to support product development.
• Oversee IND, CTA, NDA submissions and briefing documents.
• Ensure timely and accurate regulatory submissions.
• Provide regulatory input into clinical development plans and study designs.
• Collaborate with Clinical Development, CMC, Nonclinical, Quality and leadership.
• Guide study protocols and trial conduct from a regulatory perspective.
• Maintain knowledge of applicable regulatory requirements and compliance.

Skills

Regulatory leadership

Regulatory strategy

FDA interactions

Cross-functional collaboration

Communication skills

Analytical thinking

Problem-solving

Attention to detail

Education

Bachelor’s/Master’s/PharmD/PhD in life sciences

Job description

Latigo Bio is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across development programs. The role supports FDA/EMA interactions, IND submissions, and device-to-market planning, coordinating with Clinical Development, CMC, Nonclinical, and Quality teams.

You will ensure compliance with global regulations, manage regulatory vendors, and guide cross-functional teams through development to commercialization, with a focus on fast-to-market initiatives and robust