California Licensed Regulatory Affairs Executive

Job Summary

Leading global regulatory strategy and submissions from pre-IND to commercialization, the full-time California Licensed Regulatory Affairs Executive will represent regulatory interests on program teams, develop regulatory strategies, and ensure compliance while working in a hybrid capacity from San Diego, South San Francisco, or fully remote.

Key responsibilities

• Develop and execute comprehensive regulatory strategies and oversee the preparation of regulatory documents
• Act as primary liaison with the FDA and international health authorities to facilitate timely regulatory submissions and milestone discussions
• Lead regulatory activities through staff and cross-functional teams, ensuring compliance with company policies and regulations

Required qualifications

• Undergraduate degree required; advanced degree preferred
• 10+ years of relevant experience in pharma or biotech regulatory affairs, with expertise in global regulatory strategy
• Proven knowledge of US and EU regulatory affairs, including experience with NDA submission and product approval
• Strong organizational skills with the ability to prioritize multiple tasks effectively
• Experience leading and mentoring teams, with excellent interpersonal and communication skills