Associate Director, Global Regulatory Affairs

Job Title: Associate Director, Global Regulatory Affairs
Company: Biopharma
Location: San Diego, CA

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device, and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process, and genuine passion to deliver rare talent defines Brio.

Position Overview:
Our client, an oncology-focused biotech developing novel biologic immunotherapies, is seeking an Associate Director, Global Regulatory Affairs to lead regulatory strategy and execution across multiple programs. This on-site role in San Diego offers the opportunity to shape and drive global regulatory initiatives at a critical stage of clinical development.

Opportunity Highlights:

  • Develop and lead global regulatory strategies for oncology programs in development

  • Oversee the preparation, submission, and lifecycle management of key regulatory filings (INDs, NDAs, BLAs, MAAs, etc.)

  • Serve as the primary regulatory contact for global health authorities (FDA, EMA, MHRA, etc.)

  • Partner cross-functionally with Clinical, Discovery, and CMC teams to align regulatory strategy with development goals

  • Interpret evolving regulatory requirements and guide internal teams through complex regulatory challenges

  • Participate in regulatory meetings and contribute to agency negotiations and briefing packages

  • Ensure all regulatory activities are executed with precision and compliance across regions

Position Requirements:

  • Bachelor’s degree in life sciences required; advanced degree (MS, PhD, PharmD, or MD) strongly preferred

  • 8+ years of regulatory affairs experience in the biopharmaceutical industry, ideally with biologics and oncology

  • Proven track record of leading global regulatory submissions and direct interactions with agencies

  • Deep understanding of global regulatory frameworks and submission pathways

  • Exceptional project management, communication, and strategic thinking skills

  • Strong collaborative mindset with the ability to work cross-functionally in a high-growth biotech environment

We welcome the opportunity to provide a full job description upon resume review.