Director, Regulatory Affairs

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

Location:

This position can be located in Thousand Oaks, CA, San Francisco Bay Area, CA or Washington, D.C. area.

Overview:

Reporting to the Vice President of Regulatory, the Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies). This role will be responsible for developing and implementing regulatory activities to support the clinical development plans including leading submissions, managing regulatory vendors, support of regulatory interactions, and providing regulatory guidance to cross-functional teams.

Responsibilities:

Regulatory Strategy & Leadership

• Lead execution and implementation of regulatory strategies to support product development.
• Support regulatory interactions with global health authorities, including FDA, EMA, MHRA, and others.
• Provide regulatory input into clinical development plans, study designs, labeling strategies etc.
• Anticipate and mitigate regulatory risks; develop contingency plans as needed.

Submissions & Compliance

• Oversee the preparation, review, and submission of high-quality regulatory documents (INDs, CTAs, NDAs, briefing documents, etc.).
• Ensure timely regulatory submissions are complete and accurate.
• Maintain current knowledge of applicable regulatory requirements and ensure organizational compliance.
• Lead/support preparation and management of regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions.

Cross-Functional Collaboration

• Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams to integrate regulatory considerations.
• Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct.
• Quality mindset regarding CMC submissions and inspections.

Requirements:

• Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences
• Minimum of 8 years of Regulatory experience
• Direct experience leading/supporting FDA interactions
• Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical and manage process from clinical development through to commercialization planning
• US registration experience ideal
• Experience with small molecules and pain (or similar area) is preferred
• Experienced with IND submission and maintenance
• Knowledge of US procedures (fast to market procedures would be an advantage)
• Familiarity with EU CTA/MAA regulatory processes preferred
• Regulatory Project Management experience preferred
• Excellent written and verbal communication skills
• Must display strong analytical andproblem-solving skills.
• Attention to detail is essential.