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Director, Regulatory Operations
RhyGazeRegulatory Operations Director building Veeva RIM processes and global submission infrastructure for gene therapy biotech RhyGaze. Coordinating eCTD readiness, vendors, compliance, and cross-functional delivery.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in Regulatory Operations, with a strong focus on managing regulatory submissions and ensuring compliance with ICH and regional requirements. Proficient in developing and implementing regulatory processes, document management systems, and vendor management strategies.
Highest-signal resume keywords
Regulatory Operations ExperienceECTD Structure KnowledgeVeeva Basics RIM ProficiencyGlobal Submission PlanningVendor Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Information ManagementDocument Management SystemsIND Submission PreparationIMPD Submission PreparationCTA Submission PreparationQuality Control ProcessesSubmission Tracking DashboardsAudit-Trail ProcessesGCP/GMP ComplianceDocument Readiness Workflows
Soft Skills
Attention to DetailOrganizational SkillsInterpersonal SkillsStakeholder ManagementCollaboration Skills
Tools & Technologies
Veeva BasicsZenQMSECTD Validation ToolsRegulatory Submission Platforms
Industry Keywords
BiotechPharmaceuticalICH GuidelinesFDA ComplianceEMA ComplianceMHRA ComplianceHealth Canada Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Establish core Regulatory Operations processes and scalable systems from scratch
- Lead project planning for forthcoming major regulatory submissions
- Coordinate planning and execution of IND/IMPD and CTA/CTN submissions across regions
- Develop content plans and document templates as needed
- 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 with publishing vendors for eCTD build, validation, and gateway submission
- Ensure submission components meet ICH/eCTD requirements and local agency specifications
- Implement and manage RhyGaze’s Veeva Basics RIM
- Develop document readiness checklists, RIM data entry processes, and submission archive structures
- Establish submission tracking dashboards and operational KPIs
- Implement inspection-ready document control and audit-trail processes
- Serve as the operational interface between 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 submission status, timelines, risks, and mitigation strategies
- Ensure regulatory 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 related to regulatory documentation and archives
- Safeguard RIM data integrity, controlled document lineage, audit trails, and submission master files
Requirements
What you’ll need- 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
- 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
- Legally able to work in the US (US citizen or US work permit)
- Located in the Philadelphia region, or willing to travel to and work in Philadelphia for one week each month
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 Philadelphia-region location or travel to and work in Philadelphia for one week each month