A leadership role within the regulatory function, this position is responsible for overseeing key regulatory processes related to investigational product filings and ongoing compliance. Reporting to the senior leadership team, the individual will drive regulatory strategy and execution for clinical-stage programs. The role is based at the company's headquarters in San Diego.
Key Responsibilities:
Serve as the regulatory lead for clinical and development teams, ensuring alignment with global compliance requirements.
Prepare, review, and manage documentation essential for regulatory submissions, including investigational applications, periodic updates, and health authority engagement materials.
Partner closely with project managers to establish and track regulatory timelines, ensuring alignment with corporate objectives.
Supervise third-party regulatory submission partners, ensuring accuracy, adherence to guidelines, and timely delivery.
Maintain internal regulatory documentation and archives for clinical-stage projects.
Drive the creation and submission of global regulatory filings and manage responses to health authority inquiries.
Contribute to compliance initiatives such as SOP development and documentation management.
Evaluate clinical study materials-including protocols, consent documents, investigator brochures, and site documentation-to ensure regulatory compliance.
Stay informed on evolving regulatory standards in both domestic and international markets.
Support additional regulatory activities as needed, collaborating closely with senior leadership.
Uphold the organization's values, policies, and compliance obligations in all regulatory activities.
Qualifications & Experience:
Bachelor's degree required; an advanced degree is advantageous.
12+ years in the biopharma industry, with at least 8 years focused on regulatory affairs for clinical-stage programs.
Proven ability to interpret regulatory requirements and translate them into actionable strategies.
Experience developing systems and processes to streamline regulatory submissions.
Strong organizational and project management capabilities, with an eye for detail and the ability to juggle multiple priorities.
Excellent interpersonal and communication skills; capable of building cross-functional relationships and collaborating effectively.
Ability to work efficiently in a dynamic, fast-paced environment while maintaining a solutions-oriented mindset.
Passion for science, innovation, and advancing patient care.