Vice President, Regulatory Affairs

Location: Redwood City, CA | 4-5 days on-site
Focus: Biologics | Immunology & Oncology
Compensation: Competitive base salary + equity

We are partnering with an innovative clinical-stage biotech to appoint a Vice President of Regulatory Affairs to lead global regulatory strategy across a pipeline of novel biologic therapies.

This is a highly visible, hands-on position within a lean biotech environment, working closely with the CEO and leadership team to drive regulatory strategy and execution across early clinical development.

The role could also suit an experienced Executive Director ready to step into broader VP-level ownership.

The Role

• Develop and execute global regulatory strategies for biologic development programs.

• Lead regulatory activities across preclinical, Phase I and Phase II development.

• Lead IND preparation, submissions, amendments and ongoing maintenance.

• Lead interactions with the FDA and other global health authorities.

• Provide regulatory input into clinical development plans and protocols.

• Partner closely with Clinical Development, Nonclinical, CMC, Quality and executive leadership.

• Manage external CROs, regulatory consultants and vendors.

• Support regulatory strategy across the US and international markets, including Europe, APAC and Australia.

About You

• Strong biologics / large molecule regulatory experience.

• Hands-on R&D Regulatory Strategy background, rather than predominantly CMC-focused experience.

• Direct experience with INDs, FDA interactions and Phase I/II development.

• Previous experience working within a small or emerging biotech environment.

• Experience interacting with international health authorities.

• Immunology, autoimmune or oncology experience preferred, with lupus experience particularly relevant.

• Experience with ADCs or other complex biologic modalities would be advantageous.

• Comfortable working within a lean, highly outsourced biotech model.

• A hands-on, proactive approach with a strong sense of urgency, ownership and accountability.

This is an opportunity to become the senior regulatory leader within a growing biotech, with significant influence over development strategy and the progression of its pipeline.

The successful candidate will be someone who enjoys operating close to the work, making decisions and driving programs forward in a fast-paced environment.

Location: Redwood City, California
Working pattern: 4-5 days per week on-site

For further information or a confidential discussion, please apply or get in touch directly.