Role: Software Engineer – Regulatory Technology (eCTD Submission Systems)

Role Summary

This role will act as the end-to-end technical domain expert for post-authoring phases of regulatory submissions, including compilation, validation, publishing, gateway submission, and lifecycle management.

The ideal candidate brings a strong blend of regulatory operations expertise and hands-on technical/development capability, enabling seamless translation of regulatory requirements into scalable software solutions.

Key Responsibilities

Serve as the subject matter expert for the full eCTD/DMF submission lifecycle:
Compilation & assembly
XML backbone generation
Regional Module 1 handling
Validation (FDA, EMA, and other authority rules)
Publishing and packaging
Gateway submission and acknowledgements
Lifecycle management and archival
Translate regulatory workflows into:
Technical specifications
User stories
Process flows
Data models and acceptance criteria
Contribute hands-on to development by:
Prototyping (XML generators, validation engines, automation scripts)
Reviewing code and suggesting optimizations
Troubleshooting regulatory-technical issues
Conduct end-to-end testing using:
Mock submissions
Real test sequences
Regulatory gateway sandboxes
Drive product innovation:
Automation of workflows
Performance and scalability improvements
AI-driven enhancements (e.g., error correction, structure recommendations)
Collaborate with product and engineering teams to ensure alignment with:
Global regulatory standards
System architecture and design
Stay updated with regulatory changes and translate them into:
Validation rule updates
Regional configurations
Develop:
Technical documentation
Training materials
SOPs
Continuously improve product quality by analyzing submission outcomes and failure points

Required Qualifications & Experience

Must Have

8–10+ years of experience in pharmaceutical regulatory operations, with strong technical exposure
Hands-on expertise across the end-to-end eCTD submission lifecycle
Proven experience submitting to major health authorities with high technical acceptance rates
Strong programming/scripting skills:
Python (preferred)
Java / C# or similar
Technical expertise in:
XML processing (schemas, backbone generation)
PDF handling (PDF/A compliance, bookmarks, hyperlinks)
Workflow automation
Solid understanding of:
ICH eCTD standards (v3.2.2 and v4.0)
Regulatory validation rules
XML schemas and lifecycle operators
Gateway protocols (AS2, certificates, etc.)

Preferred

Experience working on or implementing regulatory submission software platforms
Exposure to building/customizing validation rules or automation frameworks
Knowledge of global regulatory environments (US, EU, and emerging markets)
Degree in Life Sciences, Pharmacy, Computer Science, or related field
Relevant certifications (e.g., RAC)

Technical Skills

Programming: Python, Java, .NET
Technologies: XML, XSLT, XPath, REST APIs, JSON
Tools:
eCTD publishing/validation tools
PDF processing tools
Regulatory Information Management (RIM) systems
Version control (Git)
Ability to:
Build prototypes
Automate workflows
Guide system design and implementation