Director, Regulatory Affairs

Latigo Biotherapeutics; Thousand Oaks (CA); On-site; USD 190,000 - 270,000; Full time

Job summary

Latigo Biotherapeutics seeks a Director of Regulatory Affairs to lead regulatory execution across development programs, ensuring FDA/EMA readiness and global compliance. You will guide submission strategy, manage regulatory vendors, and provide cross-functional regulatory guidance from discovery through commercialization planning.

The role requires strong leadership, extensive FDA experience, and a track record in IND submissions, US registration, and EU regulatory processes, with preference for

Qualifications

• Bachelor's, Master's, PharmD or PhD in life sciences.
• 8+ years regulatory experience.
• Direct experience leading/supplementing FDA interactions.
• US registration experience ideal.

Responsibilities

• Lead regulatory strategy and execution to support product development.
• Coordinate interactions with FDA/EMA/MHRA and other authorities.
• Provide regulatory input into clinical development plans and study designs.
• Oversee regulatory submissions (INDs, CTAs, NDAs) and briefings.
• Collaborate with Clinical, CMC, Nonclinical, Quality and leadership teams.

Education

Bachelor's/Master's/PhD in life sciences

Advanced/regulatory degree (optional)

Job description

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

Reporting to the Vice President of Regulatory, t he 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 implement ation of regulatory strategies to support product development .
• S upport 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
• D irect 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.