Regulatory Affairs Lead - Oncology & Personalized Therapies

Serova; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Serova is seeking a hands-on Regulatory Lead to own regulatory strategy and execution for cancer vaccines and personalized therapies. You will oversee regulatory submissions, including INDs, and navigate cross-border requirements with FDA, MHRA, EMA and TGA.

You will coordinate clinical, CMC and safety inputs, and build the pathway from single-patient INDs to expanded access and a Phase 1 trial, while fostering strong regulator relationships.

Qualifications

• Regulatory experience with the FDA on INDs, biologics or early clinical development.
• Drafted and driven submissions personally, not only managed them.
• Based in the SF Bay Area or London, or willing to relocate; authorized to work in US/UK.
• Multi-country regulatory experience including FDA, MHRA, EMA and TGA.

Responsibilities

• Set regulatory strategy for therapeutics and diagnostics.
• Run expanded access submissions end to end.
• Coordinate clinical, CMC, nonclinical and safety inputs for submissions.
• Build the regulatory roadmap from INDs to scalable expanded access and Phase 1.
• Own relationships with FDA, MHRA and other regulators.

Skills

Regulatory strategy

FDA INDs

Regulatory submissions

Multi-country submissions

Regulatory leadership

Job description

Serova is seeking a hands-on Regulatory Lead to own regulatory strategy and execution for cancer vaccines and personalized therapies. You will oversee regulatory submissions, including INDs, and navigate cross-border requirements with FDA, MHRA, EMA and TGA.

You will coordinate clinical, CMC and safety inputs, and build the pathway from single-patient INDs to expanded access and a Phase 1 trial, while fostering strong regulator relationships.