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Contact: Alexandra Spink - aspink@penfieldsearch.com
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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.

Success in This Role
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