(Associate) Director, Regulatory Operations

RhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness. Our lead program targets patients with blinding retinal diseases, and we are committed to bringing life-changing treatments to those in need. We are seeking a hands-on Regulatory Operations professional to establish core RegOps processes, lead the project planning for forthcoming major submissions, publishing vendor management, and management of internal operational platforms.

The (Associate) Director of Regulatory Operations will be responsible for cementing the implementation of Veeva RIM Basics and establishing foundational RegOps processes. This is a highly hands‑on, execution‑oriented role suited for someone comfortable operating in a fast‑moving startup environment. You will lead submission preparation, document management, metadata standards, eCTD readiness, and partner closely with Regulatory Affairs, Clinical, CMC, QA, and external vendors.

The ideal candidate brings practical experience supporting global submissions for biotech programs and is motivated by building scalable systems from scratch.

Tasks

Regulatory Submission Planning & Execution

• Coordinate planning and execution of regulatory submissions (IND/IMPD, CTA/CTN) across regions including content plans, document templates as needed.
• Build and manage integrated project plans (critical path, dependencies, risks); drive on-time, right-first-time delivery.
• Manage document readiness workflows: authoring, QC, formatting, approval routes.
• Coordinate with publishing vendors for eCTD build, validation, and gateway submission.
• Ensure all submission components meet ICH/eCTD requirements and local agency specifications.

RegOps Infrastructure & Process Buildout

• Implement and manage RhyGaze’s Veeva Basics RIM and develop foundational RegOps processes including: Document readiness checklists.
• RIM data entry processes.
• Submission archive structure.
• Establish submission tracking dashboards and operational KPIs suitable for an early‑stage biotech organization.
• Implement processes to ensure inspection‑ready document control and audit trails.

Cross-Functional Collaboration & Vendor Coordination

• Serve as the operational interface between Regulatory Affairs, Medical Writing, CMC, Nonclinical, Clinical, QA, and external partners.
• Manage publishing vendor relationships, including timelines, quality oversight and validation review.
• When needed take on publishing responsibilities within Veeva Basics RIM.
• Provide clear reporting on submission status, timelines, risks, and mitigation strategies.

Compliance & Quality

• Ensure regulatory documentation and submissions complywith ICH, FDA, EMA, MHRA, Health Canada, and regional regulatory document requirements.
• Develop quality gates and review processes to drive right‑first‑time delivery.
• Support inspection readiness (GCP/GMP) related to regulatory documentation and archives.
• Safeguard RIM data integrity and controlled document lineage; maintain audit trails and submission master files.

Requirements

Education & Experience

• 8+ years experience in Regulatory Operations, ideally within biotech or small/mid-size pharma.
• Hands-on experience with regulatory information management or document management systems (e.g., Veeva Basics and/or ZenQMS or similar platforms).
• Proven track record in planning and preparing global submissions (IND, IMPD, CTA, HA interactions).
• Strong understanding of eCTD structure, ICH guidelines, and regional requirements.
• Ability to operate independently with minimal infrastructure and build processes from scratch.
• Experience working with publishing vendors and reviewing validation reports.
• Exceptional attention to detail, organizational skills, and comfort with ambiguity.

Knowledge & Skills

• In-depth knowledge of global eCTD requirements (FDA, EMA, ICH).
• Strong vendor management experience.
• Strong stakeholder management skills.
• Excellent communication and interpersonal skills, with ability to collaborate across functions.
• Ability to balance compliance, and operational agility.

Benefits

Why Join Us

• Opportunity to help develop breakthrough therapies for patients with serious vision-threatening diseases.
• Work alongside a passionate, highly experienced team at the forefront of ophthalmology innovation.
• Meaningful impact in a growing biotech company.
• Collaborative, entrepreneurial culture where science and innovation drive decision-making.

We are seeking candidates located in the Philadelphia region, as well as candidates who are willing to travel to and work in Philadelphia for one week each month.

Candidates needs legally able to work in the US (US citizen or US work permit).