Director, Regulatory Operations — Biotech Submissions

RhyGaze; Philadelphia (Philadelphia County); On-site; USD 150,000 - 230,000; Full time

Job summary

RhyGaze, a biotech company focused on transformative gene therapies for retinal diseases, seeks a hands-on Associate Director of Regulatory Operations. You will implement Veeva RIM Basics, establish core RegOps processes, and lead global submissions planning and document management in a fast‑moving startup environment.

You will manage publishing vendors, drive eCTD readiness, and collaborate with Regulatory Affairs, Clinical, CMC, QA, and external partners to ensure right‑first‑time delivery and

Qualifications

• 8+ years of Regulatory Operations experience in biotech or pharma.
• Hands-on experience with regulatory information management or document management systems.
• Proven track record planning and preparing global submissions (IND/IMPD, CTA/CTN).
• Strong understanding of eCTD structure and ICH guidelines.
• Ability to work independently and build processes from scratch.
• Experience with publishing vendors and validating reports.

Responsibilities

• Regulatory Submission Planning & Execution across regions with content plans and templates.
• Build integrated project plans with critical paths, risks, and dependencies.
• Coordinate with publishing vendors for eCTD build, validation, and gateway submission.
• Develop RegOps infrastructure including RIM processes and dashboards.
• Serve as operational interface between Regulatory Affairs, Medical Writing, CMC, QA, and vendors.
• Maintain inspection readiness and audit trails for regulatory documentation.

Skills

Regulatory Operations

Vendor Management

Stakeholder Management

Project Planning

eCTD Knowledge

Regulatory Information Management

Cross-functional Collaboration

Attention to Detail

Tools

Veeva Basics

ZenQMS

Job description

RhyGaze, a biotech company focused on transformative gene therapies for retinal diseases, seeks a hands-on Associate Director of Regulatory Operations. You will implement Veeva RIM Basics, establish core RegOps processes, and lead global submissions planning and document management in a fast‑moving startup environment.

You will manage publishing vendors, drive eCTD readiness, and collaborate with Regulatory Affairs, Clinical, CMC, QA, and external partners to ensure right‑first‑time delivery and