Regulatory affairs lead

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

About Serova

Serova builds personalized cancer vaccines. Each vaccine is made for the individual patient from their own samples and given in partnership with their treating physician. We work with the FDA to get patients access through expanded access today, and we're building toward trials.

The role

You'll own regulatory strategy and execution for our therapeutics: the cancer vaccine program and our personalized therapies. That's the core of the job. We also run sequencing and tests, so diagnostics experience would be useful too.

What you'll do

• Set regulatory strategy for our therapeutics: the cancer vaccine program and our personalized therapies

• Support regulatory work on our diagnostics: our sequencing work, research-use versus CLIA requirements, and any test we take to market

• Run expanded access submissions end to end across many concurrent cases: drafting single-patient INDs, FDA interactions, amendments and follow-ups

• Coordinate the clinical, CMC, nonclinical and safety inputs to each submission

• Build the roadmap from single-patient INDs to scalable expanded access, and then a Phase 1 trial

• Own our relationships with the FDA, MHRA and other regulators, and trial submissions

• Handle import and export across regions, and pick the right route for each case (expanded access or a trial)

• Work with quality and manufacturing where CMC and GMP feed into submissions

• Review patient-facing materials and advise our Bozeman clinic

• Build out the regulatory function, including external advisors

Who you are

• A hands-on regulatory lead who drafts submissions yourself

• You find the way to do things within the rules while we move fast

• You give clear answers, even when the answer is "untested"

• Comfortable being the only regulatory person here for a while

• High agency, friendly and low ego

Requirements

• Regulatory experience with the FDA on INDs, biologics or early clinical development

• You've drafted and driven submissions personally, not only managed them

• Based in the San Francisco Bay Area or London, or willing to relocate

• Authorized to work in the US or UK, or a realistic path to get there

What will make you stand out

• Expanded access and single-patient INDs, including running many concurrent cases

• Diagnostics regulation: research-use versus CLIA requirements, or taking a test to market

• Multi-country experience: MHRA, EMA and Australia's TGA as well as the FDA

• Oncology, personalized or advanced therapies

• CMC and GMP knowledge for IND submissions

• FDA expedited programs: Fast Track, Breakthrough Therapy, Accelerated Approval

• Import and export rules across regions

Details

• Location: San Francisco or London

• Type: Full-time preferred; fractional considered