Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

Huntington Beach, CA | $260,000–$300,000 Base + 30%+ Target Bonus + Benefits + Relocation Assistance

A patient-focused biotechnology organization is hiring a senior regulatory executive to provide enterprise leadership across Regulatory Affairs, Clinical Operations and Medical Affairs .

This role is ideal for an experienced biotechnology leader who has successfully guided complex regulatory submissions, worked directly with the FDA, and overseen clinical development and Medical Affairs programs. The position offers significant executive visibility and the opportunity to shape the future of an established oncology and cellular immunotherapy platform.

Actual worksite: Seal Beach, California 90740. This position requires onsite presence.

Key Responsibilities

• Set global regulatory strategy for commercial products, clinical programs, manufacturing changes and future pipeline initiatives

• Lead IND, BLA, amendment, supplement and post-approval submission activities

• Represent the organization in FDA meetings, health authority interactions, inspections and regulatory responses

• Oversee clinical trial execution, CROs, vendors, budgets, timelines, enrollment and operational risk

• Guide Medical Affairs strategy, scientific publications, advisory boards, KOL relationships and medical education

• Support investigator-sponsored studies, real-world evidence and post-marketing clinical programs

• Ensure compliance with FDA requirements, GCP, ICH, GMP and applicable global regulations

• Advise executive leadership on regulatory, clinical and medical risks and opportunities

• Establish departmental objectives, budgets, KPIs and long-term organizational plans

• Recruit, develop and lead high-performing regulatory and clinical teams

Required Background

• MS, PharmD, PhD, MD or equivalent advanced scientific degree

• 15+ years in biotechnology, pharmaceuticals or biopharmaceuticals

• 10+ years of Regulatory Affairs leadership

• Successful IND and BLA submission leadership

• Direct FDA and health authority meeting experience

• Significant Clinical Operations and clinical trial oversight experience

• Medical Affairs, scientific communications and KOL engagement experience

• Product development, approval, commercialization and lifecycle management experience

• Oncology, immunotherapy, cell therapy, cellular therapy or biologics experience preferred

• Experience managing multidisciplinary teams, CROs, vendors and consultants

• Willingness to work onsite in Seal Beach, California

• Availability for up to 30% domestic and international travel

Opportunity Highlights

• Commercial-stage biotechnology organization

• Established FDA-approved cellular immunotherapy platform

• Executive ownership across Regulatory Affairs, Clinical Operations and Medical Affairs

• Direct interaction with senior leadership and board members

• Meaningful influence over commercial and pipeline strategy

• Executive bonus opportunity and relocation assistance

MOHR Talent is an equal-opportunity employer and complies with all applicable federal, state, and local nondiscrimination laws. We provide equal employment opportunities regardless of race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, genetic information, military/veteran status, or any other protected status. If you believe you have been discriminated against or have concerns about our compliance, please contact our Human Resources department at ***email_hidden***