Director, Regulatory Operations

Jobtailor; Philadelphia (Philadelphia County); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor is seeking a Regulatory Operations lead in the Philadelphia area to establish scalable systems and manage global submissions. You will own planning for IND/IMPD and CTA/CTN submissions, coordinate cross-region efforts, and ensure ICH/eCTD compliance across all documentation.

The role requires extensive experience with regulatory information management systems, vendor oversight, and strong cross-functional collaboration with Medical Writing, QA, and clinical teams.

Qualifications

• 8+ years experience in Regulatory Operations or closely related field.
• Hands-on with regulatory information management or document management systems (Veeva Basics, ZenQMS).
• Proven track record in planning global submissions (IND/IMPD/CTA).
• Strong knowledge of eCTD structure and regional requirements (FDA/EMA/ICH).
• Independent operator able to build processes from scratch.
• Experience with publishing vendors, validation reports, and audit trails.

Responsibilities

• Establish core Regulatory Operations processes and scalable systems from scratch.
• Lead planning for forthcoming major regulatory submissions and IND/IMPD/CTA initiatives.
• Coordinate submissions across regions and manage eCTD components to meet ICH/ICH guidelines.

Skills

Regulatory Operations

Veeva Basics RIM

Global Submission Planning

Vendor Management

GCP/GMP Compliance

eCTD Knowledge

ICH Guidelines

Stakeholder Management

Tools

Veeva Basics

ZenQMS

ECTD Validation Tools

Job description

• 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

• 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

Core Competencies

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 Experience
• ECTD Structure Knowledge
• Veeva Basics RIM Proficiency
• Global Submission Planning
• Vendor Management Skills

ATS Optimization Keywords

Hard Skills

• Regulatory Information Management
• Document Management Systems
• IND Submission Preparation
• IMPD Submission Preparation
• CTA Submission Preparation
• Quality Control Processes
• Submission Tracking Dashboards
• Audit-Trail Processes
• GCP/GMP Compliance
• Document Readiness Workflows

Soft Skills

• Attention to Detail
• Organizational Skills
• Interpersonal Skills
• Stakeholder Management
• Collaboration Skills

Industry Keywords

• Biotech
• Pharmaceutical
• ICH Guidelines
• FDA Compliance
• EMA Compliance
• MHRA Compliance
• Health Canada Regulations

Tools & Technologies

• Veeva Basics
• ZenQMS
• ECTD Validation Tools
• Regulatory Submission Platforms