Senior Regulatory Submission Lead

Job Description

Contact:
Alexandra Spink
- No 3rd party candidates

Location:

Bay Area-based role
Work Model: 5 days onsite per week

We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module
5. This 1 year contract role will provide hands-on submission execution and cross-functional coordination to ensure regulatory content is aligned, complete, and ready for filing.

• Coordinate BLA submission activities across Module 2 and Module 5, including timelines, deliverables, and submission readiness.
• Support preparation and review of submission content, including CSRs, appendices, ISS, ISE, and related regulatory documentation.
• Ensure clinical and biometrics outputs are incorporated into accurate, regulatory-ready submission content.
• Manage submission documentation, QC, version control, and workflows within Veeva Vault.
• Support eCTD publishing activities and FDA-facing submission needs.
• Identify gaps, track dependencies, and help maintain submission timelines.

• 7+ years of experience supporting regulatory submissions within the life sciences industry.
• Advanced scientific or clinical training preferred (PhD, PharmD, or MD), with prior ophthalmology experience strongly preferred.
• Hands-on BLA submission experience with strong knowledge of FDA Module 2 and Module 5 requirements.
• Experience independently coordinating submission activities from planning through filing, including FDA interactions and regulatory communications.
• Hands-on experience using Veeva Vault to support regulatory submissions, including document management, workflows, QC, and submission readiness, with a strong understanding of eCTD processes and publishing activities.

The successful candidate will quickly step into an active BLA submission environment, coordinate across functions, and help ensure Module 2 and Module 5 deliverables remain aligned and submission-ready through filing.

Hourly Rate: $120-$175/hour