Product Development / Regulatory Technology

Location: Hyderabad (Hybrid/On-site preferred) or Remote (India/Global)

Reports To: Product Head / CTO

Role Type: Full-time / Contract-to-Hire (initial 6–12 months)

Role Summary

We are enhancing Harmony, our AI-powered authoring and lifecycle management platform for Dossiers and DMFs, with a new Submission Module. You will serve as the end-to-end technical domain expert for post-authoring phases (compilation, validation, publishing, gateway submission, and lifecycle management).

You combine deep regulatory operations knowledge with technical/software skills to bridge the gap between regulatory requirements and implementation. You will define precise features, validate implementations, prototype solutions, and continuously improve the product so it delivers a seamless, compliant, and superior experience compared to tools like DocuBridge and pharmaREADY. Your developer background will help our existing engineering team (strong coders but new to regulatory systems) build accurately and efficiently.

Key Responsibilities

• Act as the primary domain authority on the full eCTD/DMF submission lifecycle: assembly & compilation, XML backbone generation, regional Module 1 handling, technical validation (FDA/EMA/HC rulesets), publishing (ZIP packages), secure gateway transmission, acknowledgement handling, amendments, and archival.
• Translate complex regulatory workflows, validation criteria, and edge cases into detailed technical specifications, user stories, process flows, data models, and acceptance criteria for the development team.
• Leverage your developer experience to prototype features (e.g., XML generators, validation rule engines, PDF processors, automation scripts), review code, suggest optimisations, and troubleshoot technical issues in regulatory contexts.
• Perform hands-on testing and validation of the module using real test sequences, mock submissions, and official gateway sandboxes (FDA ESG, EMA test environment, etc.).
• Drive product improvement initiatives: identify technical enhancements for performance, scalability, automation, AI integration (e.g., intelligent error fixing or structure suggestions), and better integration with Harmony’s existing
  authoring/DMS capabilities.
• Collaborate closely with the Product Architect and development team to ensure architecture decisions align with real-world regulatory standards (ICH eCTD v3.2.2/v4.0, 21 CFR Part 11, global gateway protocols).
• Maintain up-to-date knowledge of regulatory changes and translate them into actionable product updates (validation rule matrices, regional templates, etc.).
• Create technical documentation, training materials, and SOPs to upskill the internal team and support future customers.
• Contribute to continuous improvement by analysing submission failures, proposing automation opportunities, and enhancing overall product quality and usability.

Required Qualifications & Experience 

Must-have :

• 8–10+ years of combined experience in pharmaceutical regulatory operations with a strong technical/developer component.
• Hands-on expertise in the complete end-to-end eCTD submission lifecycle using industry tools (DocuBridge/Lorenz, pharmaREADY, EXTEDO, GlobalSubmit, Liquent, or similar).
• Proven success in preparing and submitting eCTD packages to major authorities (FDA ESG, EMA eSubmission Gateway, Health Canada CESG) with high first-pass technical acceptance.
• Developer / technical experience: Proficiency in scripting or programming (Python preferred for XML/PDF automation; also Java, C#, or similar). Experience with XML processing (schema validation, backbone generation), PDF manipulation (Adobe Acrobat SDK, PDF/A compliance, hyperlinks/bookmarks), automation of validation/publishing workflows, or integration between DMS and submission systems.
• Strong knowledge of technical standards: ICH eCTD specifications (v3.2.2 and v4.0), FDA/EMA validation criteria, PDF/A requirements, XML schemas, checksums, lifecycle operators, and gateway protocols (AS2, certificates, etc.).

Strongly Preferred:

• Prior experience in a regulatory software company (Lorenz, EXTEDO, Certara, Freyr or similar) or in implementing/customising eCTD/publishing systems.
• Experience contributing to or building features in submission tools (e.g., custom validation rules, automation scripts, integration layers).
• Exposure to emerging markets (CDSCO India, NMPA China, PMDA, TGA) is a plus.
• Bachelor’s or Master’s in Life Sciences, Pharmacy, Computer Science, or related field. RAC certification or equivalent is advantageous.

Technical Skills :

• Programming/Scripting: Python (highly desired for XML & automation), Java/.NET, or equivalent.
• Technologies: XML/XSLT/XPath, PDF processing libraries/tools, REST APIs, JSON, database handling for metadata.
• Tools: Experience with eCTD publishing/validation software, Adobe Acrobat Professional, regulatory information management (RIM) systems, and version control (Git).
• Ability to write prototypes, automate repetitive tasks, and guide backend/frontend implementation of regulatory logic.

Soft Skills

• Lead and mentor a team of junior developers.
• Excellent at explaining regulatory and technical concepts to non-domain developers.
• Strong problem-solving, attention to detail, and collaborative mindset.
• Ability to drive product improvements proactively.

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