Regulatory Operations Lead – Global Submissions

RhyGaze AG; Philadelphia (Philadelphia County); On-site; Confidential; Full time

Job summary

RhyGaze AG is seeking a hands-on Regulatory Operations Director to establish core RegOps processes, lead major submission planning, and manage publishing vendors. You will implement Veeva RIM basics, build scalable systems, and partner with Regulatory Affairs, Clinical, CMC, and QA in a fast-growing biotech startup.

The role focuses on submission planning, document management, metadata standards, eCTD readiness, and developing KPIs and dashboards for an early-stage organization.

Qualifications

• 8+ years experience in Regulatory Operations or related role in biotech/pharma.
• Hands-on experience with regulatory information management systems (Veeva Basics, ZenQMS).
• Proven track record in planning and preparing global submissions (IND/IMPD, CTA/CTN).
• Strong understanding of eCTD, ICH guidelines, and regional requirements.
• Ability to build processes from scratch in a fast-moving startup environment.
• Experience working with publishing vendors and reviewing validation reports.

Responsibilities

• Plan and execute regulatory submissions (IND/IMPD, CTA/CTN) across regions, including content plans and templates.
• Develop and manage integrated project plans with critical paths and risks.
• Oversee document readiness workflows from authoring to approval routing.
• Coordinate with publishing vendors for eCTD build, validation and gateway submissions.
• Ensure submissions meet ICH/eCTD requirements and local agency specs.
• Implement and run RegOps infrastructure including Veeva RIM and dashboards.
• Serve as operational partner between Regulatory Affairs, Clinical, QA, CMC and external vendors.
• Maintain inspection readiness through robust document controls and audit trails.

Skills

Vendor management

Regulatory operations

Project planning

Stakeholder management

Communication

Attention to detail

Audit readiness

Tools

Veeva Basics

ZenQMS

Job description

RhyGaze AG is seeking a hands-on Regulatory Operations Director to establish core RegOps processes, lead major submission planning, and manage publishing vendors. You will implement Veeva RIM basics, build scalable systems, and partner with Regulatory Affairs, Clinical, CMC, and QA in a fast-growing biotech startup.

The role focuses on submission planning, document management, metadata standards, eCTD readiness, and developing KPIs and dashboards for an early-stage organization.