Regulatory Affairs Specialist

Vaxart • South San Francisco, CA

5d • $65,000 - $80,000 • Onsite

About The Position

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. We are looking for a Regulatory Affairs Specialist to join our South San Francisco team. This is an onsite position in our South San Francisco Office.

Requirements

• Associate or bachelor’s degree in a scientific discipline or related field (biology, biochemistry, public health, regulatory science, etc.).
• 1–3 years of experience in biotechnology, pharmaceuticals, or a related regulated industry.
• Excellent interpersonal, verbal, and written communications skills.
• Reliable, adaptable and execution oriented.
• Strong attention to detail with the ability to manage and meet deadlines.
• Self-starter, process oriented with strong organizational skills.
• Highly collaborative, able to adapt as needed with strong time management skills.
• Ability to manage multiple tasks and deadlines in a fast-paced environment.
• Proficiency with document management tools (e.g., Veeva) and MS Office.

Nice To Haves

• Experience supporting regulatory submissions, especially eCTD formats.
• Familiarity with FDA, EMA, ICH, and WHO regulatory guidance for vaccines or biologics.
• Knowledge of GMP, GLP, and GCP environments.
• Experience in vaccine development or biologics manufacturing.

Responsibilities

• Assist in compiling, formatting, and organizing sections of regulatory submissions (e.g., INDs, IMPDs, BLAs, CTAs, annual reports).
• Maintain document control, version tracking, and archive management according to internal SOPs.
• Support the preparation of regulatory correspondence and briefing materials for interactions with FDA, EMA, and other global agencies.
• Collect, review, and verify data from Quality, Manufacturing, Nonclinical, and Clinical teams for accuracy and completeness.
• Perform QC checks on tables, figures, and technical data to ensure regulatory-compliant formatting.
• Help ensure consistency of terminology, study identifiers, and product descriptions across documents.
• Maintain regulatory databases, submission trackers, and timelines.
• Upload, organize, and manage documents in electronic document management systems (EDMS).
• Support eCTD structure preparation by organizing files according to module requirements.
• Assist in maintaining regulatory SOPs and tracking updates.
• Support audits and inspections by preparing document packages and ensuring readiness.
• Track regulatory commitments and ensure deadlines are met.
• Schedule regulatory meetings, take minutes, and track action items.
• Coordinate with functional teams (CMC, Quality, Clinical, Nonclinical, Program Management) to gather submission inputs.
• Support review cycles by managing calendars, distributing drafts, and tracking comments.
• Other duties as assigned by Head of Regulatory and/or CMO

Benefits

• Vaxart offers team members a competitive compensation and benefits package, including robust health plan options, bonus program, stock options, 401(k) with employer matching, tuition assistance, commuter benefits, and work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees