Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs

Long Beach, CA | $260,000–$300,000 Base + Executive Bonus + Benefits + Relocation Assistance

About the Role

A commercial-stage biotechnology company is seeking an accomplished executive to lead its Regulatory Affairs, Clinical Operations, and Medical Affairs functions. This is a highly visible, onsite leadership opportunity supporting an established commercial therapy, ongoing clinical and lifecycle programs, and future oncology and cell therapy initiatives. The Vice President will work closely with executive leadership and cross-functional partners to connect regulatory strategy, clinical execution, and medical direction across the organization.

Responsibilities

• Develop and execute global regulatory strategies supporting clinical development, manufacturing changes, commercialization, and lifecycle management
• Lead INDs, BLAs, amendments, supplements, annual reports, and responses to regulatory agencies
• Serve as a senior company representative in meetings with the FDA and international health authorities
• Oversee clinical trial planning, CRO performance, study budgets, timelines, enrollment, risk management, and inspection readiness
• Direct Medical Affairs strategy, scientific communications, KOL engagement, publications, and evidence-generation activities
• Review promotional and non-promotional materials for scientific accuracy and regulatory compliance
• Partner with Quality, Manufacturing, Commercial, Pharmacovigilance, and executive leadership
• Build, lead, and mentor Regulatory Affairs and Clinical Operations teams
• Present regulatory, clinical, and medical strategies to executive leadership and board-level stakeholders

Requirements

• Advanced scientific or medical degree required: MS, PharmD, PhD, MD, or equivalent
• 15+ years of progressive biotechnology or pharmaceutical industry experience
• 10+ years leading Regulatory Affairs functions
• Demonstrated leadership of IND and BLA submissions
• Significant direct interaction with the FDA and other health authorities
• Strong Clinical Operations and clinical trial execution experience
• Experience leading Medical Affairs strategy, scientific communications, and KOL engagement
• Background supporting products through development, approval, commercialization, and lifecycle management
• Oncology, immunotherapy, cell therapy, or biologics experience strongly preferred
• Executive-level team leadership and cross-functional influence
• Ability to work onsite in Seal Beach, California
• Ability to travel up to 30%

Benefits

• Lead three critical functions in one enterprise-level executive role
• Influence the direction of an established commercial-stage biotechnology platform
• Work directly with executive leadership and board-level stakeholders
• Shape regulatory strategy, clinical execution, and medical engagement
• Support therapies designed to make a meaningful difference in cancer patients’ lives
• Competitive executive compensation and relocation support

Pay

$260,000–$300,000 Base + Executive Bonus + Benefits + Relocation Assistance