Director, Regulatory Operations

RhyGaze

. Establish core Regulatory Operations processes .

Posted 9/15/2026full-timePhiladelphia • Pennsylvania • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Regulatory Operations, focusing on eCTD submissions, document management, and compliance with ICH and regional requirements. Proficient in managing vendor relationships and leading cross-functional collaboration to ensure timely and accurate regulatory submissions.

Highest-signal resume keywords

Regulatory Operations ExperienceECTD Submission ExpertiseVeeva Basics RIM ProficiencyGlobal Submission PlanningVendor Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Information ManagementDocument Management SystemsECTD Structure UnderstandingSubmission PreparationMetadata StandardsDocument Readiness WorkflowsQuality ControlSubmission Tracking DashboardsAudit Trails ManagementGCP/GMP Compliance

Soft Skills

Attention to DetailOrganizational SkillsStakeholder ManagementInterpersonal SkillsAbility to Operate Independently

Tools & Technologies

Veeva BasicsZenQMSPublishing Vendor Platforms

Industry Keywords

IND SubmissionsIMPD SubmissionsCTA SubmissionsICH GuidelinesFDA ComplianceEMA ComplianceMHRA ComplianceHealth Canada Regulations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Establish core Regulatory Operations processes
Lead project planning for forthcoming major submissions
Manage publishing vendors and internal operational platforms
Implement Veeva RIM Basics and establish foundational RegOps processes
Lead submission preparation, document management, metadata standards, and eCTD readiness
Partner with Regulatory Affairs, Clinical, CMC, QA, and external vendors
Coordinate planning and execution of IND/IMPD and CTA/CTN submissions across regions
Build and manage integrated project plans covering critical paths, dependencies, and risks
Drive on-time, right-first-time delivery
Manage document readiness workflows, including authoring, QC, formatting, and approval routes
Coordinate eCTD build, validation, and gateway submission with publishing vendors
Ensure submission components meet ICH/eCTD requirements and local agency specifications
Implement and manage Veeva Basics RIM
Develop document readiness checklists, RIM data entry processes, and submission archive structure
Establish submission tracking dashboards and operational KPIs
Implement inspection-ready document control and audit trails
Serve as operational interface among Regulatory Affairs, Medical Writing, CMC, Nonclinical, Clinical, QA, and external partners
Manage publishing vendor timelines, quality oversight, and validation review
Take on publishing responsibilities within Veeva Basics RIM when needed
Report on submission status, timelines, risks, and mitigation strategies
Ensure documentation and submissions comply with ICH, FDA, EMA, MHRA, Health Canada, and regional requirements
Develop quality gates and review processes
Support GCP/GMP inspection readiness for regulatory documentation and archives
Safeguard RIM data integrity and controlled document lineage; maintain audit trails and submission master files

Requirements

What you’ll need

8+ years of experience in Regulatory Operations, ideally within biotech or small/mid-size pharma
Hands-on experience with regulatory information management or document management systems, such as Veeva Basics and/or ZenQMS or similar platforms
Proven track record in planning and preparing global submissions, including IND, IMPD, CTA, and health authority 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 and organizational skills
Comfort with ambiguity
In-depth knowledge of global eCTD requirements for FDA, EMA, and 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
Candidates must be legally able to work in the US (US citizen or US work permit)

Benefits

Comp & perks

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
Hybrid work arrangement with candidates located in the Philadelphia region, or willingness to travel to and work in Philadelphia for one week each month