RhyGaze is a biotechnology company developing gene therapies aimed at restoring vision. Its work focuses on genetic and biologic approaches for ocular diseases, bringing together biotechnology, healthcare, and pharmaceutical research in pursuit of new treatments for vision loss. The company operates as a small team working at the intersection of scientific discovery and vision restoration.
Director of Regulatory Operations | RhyGaze | Philadelphia Hybrid
Lead regulatory operations for gene therapy development, building Veeva RIM processes and global submission systems. Help advance treatments intended to restore vision for patients affected by blindness.
Description
- Plan and coordinate regional regulatory submissions, including IND, IMPD, CTA, and CTN filings, with content plans and document templates
- Create and maintain integrated project plans that track critical paths, dependencies, and risks
- Drive submissions toward timely, right-first-time delivery
- Oversee document-readiness workflows spanning authoring, quality control, formatting, and approvals
- Coordinate eCTD publishing, validation, and gateway submissions with external vendors
- Verify that submission components satisfy ICH/eCTD standards and local agency requirements
- Implement and manage RhyGaze’s Veeva Basics RIM system
- Build core Regulatory Operations processes, including readiness checklists, RIM data-entry procedures, and submission archives
- Create submission-tracking dashboards and operational performance indicators
- Establish inspection-ready document controls and audit-trail procedures
- Act as the operational link among Regulatory Affairs, Medical Writing, CMC, Nonclinical, Clinical, QA, and external partners
- Oversee publishing vendors, schedules, quality controls, and validation reviews
- Handle publishing activities in Veeva Basics RIM as required
- Report on submission progress, timelines, risks, and mitigation actions
- Maintain compliance with ICH, FDA, EMA, MHRA, Health Canada, and other regional regulatory requirements
- Create quality gates and review procedures that support right-first-time submissions
- Support GCP/GMP inspection readiness for regulatory documents and archives
- Protect RIM data integrity and controlled document lineage while maintaining audit trails and submission master files
Requirements
- At least eight years of Regulatory Operations experience, preferably in biotechnology or small to midsize pharmaceuticals
- Practical experience with regulatory information or document management systems, such as Veeva Basics, ZenQMS, or comparable platforms
- Demonstrated success planning and preparing global submissions, including IND, IMPD, CTA, and health-authority interactions
- Strong command of eCTD structure, ICH guidance, and regional submission requirements
- Ability to work independently with limited infrastructure while establishing processes from the ground up
- Experience managing publishing vendors and reviewing validation reports
- Meticulous, highly organized, and comfortable working through ambiguity
- Deep knowledge of global eCTD requirements, including FDA, EMA, and ICH expectations
- Proven vendor management capability
- Strong stakeholder management skills
- Excellent communication and interpersonal skills for cross-functional collaboration
- Ability to balance regulatory compliance with operational flexibility
- Must be legally authorized to work in the United States as a citizen or holder of a US work permit
Benefits
- Contribute to the development of potential therapies for serious vision-threatening diseases
- Work with an experienced, committed team advancing ophthalmology innovation
- Make a meaningful contribution within a growing biotechnology company
- Join a collaborative, entrepreneurial environment where scientific evidence and innovation guide decisions
- Hybrid arrangement for candidates in the Philadelphia area or those able to travel to Philadelphia and work there for one week each month