Regulatory Operations Lead — Biotech Submissions

RhyGaze AG; Pennsylvania; On-site; Confidential; Full time

Job summary

RhyGaze AG is seeking a hands-on Regulatory Operations professional to establish core RegOps processes, lead major submissions, and manage internal platforms. The Associate Director will implement Veeva RIM Basics, lead document management, and collaborate with Regulatory Affairs, Clinical, CMC, QA, and vendors.

The ideal candidate has 8+ years in Regulatory Operations, strong ICH/eCTD knowledge, and a track record of global submissions.

Qualifications

• 8+ years experience in Regulatory Operations, preferably biotech or small/mid-size pharma.
• Hands-on experience with regulatory information management or document management systems (e.g., Veeva Basics and/or ZenQMS).
• 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.
• Excellent attention to detail and organizational skills.

Responsibilities

• Regulatory Submission Planning & Execution: coordinate planning and execution of submissions across regions; content plans and templates.
• Build and manage integrated project plans; drive on-time, right-first-time delivery.
• Manage document readiness workflows: authoring, QC, formatting, approvals.
• Coordinate with publishing vendors for eCTD build, validation, and gateway submission.
• Ensure submission components meet ICH/eCTD and local agency requirements.

Skills

Regulatory Operations

eCTD knowledge

Vendor management

Project planning

Stakeholder management

Tools

Veeva Basics

ZenQMS

Job description

RhyGaze AG is seeking a hands-on Regulatory Operations professional to establish core RegOps processes, lead major submissions, and manage internal platforms. The Associate Director will implement Veeva RIM Basics, lead document management, and collaborate with Regulatory Affairs, Clinical, CMC, QA, and vendors.

The ideal candidate has 8+ years in Regulatory Operations, strong ICH/eCTD knowledge, and a track record of global submissions.