Senior Regulatory Affairs Associate - Publishing

Ddreg Pharma; Gurugram District; On-site; INR 700,000 - 1,400,000; Full time

Job summary

DDReg Pharma Pvt. Ltd. is seeking a Regulatory Publishing Specialist in India to manage preparation, publishing, validation, submission, archiving, and lifecycle management of global regulatory submissions using eCTD tools like DocuBridge and Lorenz.

You will ensure compliance with FDA, EMA, ICH, and other global standards while coordinating with Regulatory Affairs, Medical Writing, CMC, QA, Clinical and Pharmacovigilance teams to deliver high-quality submissions on time.

Qualifications

• Experience with eCTD publishing for regulatory submissions.
• Understanding of FDA, EMA, ICH and regional standards.
• Ability to collaborate with medical writing, QA, CMC and regulatory teams.

Responsibilities

• Publish initial applications, supplements, variations and lifecycle submissions using DocuBridge, Lorenz, or equivalents.
• Assemble and publish regulatory packages per regional/global requirements.
• Ensure timely electronic submissions to authorities.
• Support lifecycle management of eCTD submissions; handle sequences, replacements, amendments, withdrawals.
• Check accuracy of submission components before dispatch.

Skills

eCTD publishing

Regulatory submissions

Cross-functional collaboration

Tools

DocuBridge

Lorenz

Job description

Job Description

Position: Regulatory Publishing Specialist
Department: Regulatory Affairs
Reporting To: Regulatory Operations Manager / Head Regulatory Affairs
Company DDReg Pharma Pvt. Ltd.

Job Purpose

The Regulatory Publishing Specialist will be responsible for the preparation, compilation, publishing, validation, submission, archiving, and lifecycle management of global regulatory submissions using eCTD publishing tools such as DocuBridge and Lorenz.
The role ensures that regulatory submissions comply with applicable health authority requirements, including FDA, EMA, and other global regulatory agencies. The incumbent will collaborate with cross-functional teams to ensure high-quality submissions are delivered accurately and within defined timelines.

1. Regulatory Submission Publishing

• Publish initial applications, supplements, variations, annual reports, renewals, responses, and lifecycle maintenance submissions using DocuBridge, Lorenz, or equivalent publishing tools.
• Compile, assemble, and publish regulatory submission packages in accordance with regional and global regulatory requirements.
• Ensure the accurate and timely delivery of electronic submissions to regulatory authorities.
• Support the complete lifecycle management of eCTD submissions, including sequences, replacements, amendments, and withdrawals.
• Verify that all submission components are complete and correctly placed before dispatch.

2. eCTD Compliance and Quality Management

• Ensure that regulatory submissions comply with FDA, EMA, ICH, and other applicable regional eCTD standards.
• Perform technical validation and quality-control checks before submission.
• Review submission structures, metadata, hyperlinks, bookmarks, file formats, naming conventions, and document placement.
• Identify, investigate, and rectify technical validation errors before submission dispatch.
• Maintain high standards of submission accuracy, consistency, and technical quality.

3. Submission Planning and Cross-Functional Coordination

• Coordinate with Regulatory Affairs, Medical Writing, CMC, Quality, Clinical, Pharmacovigilance, and other stakeholders to ensure submission readiness.
• Participate in submission planning meetings, project discussions, and milestone reviews.
• Track submission timelines, deliverables, dependencies, and risks.
• Follow up with stakeholders to obtain required documents and information within agreed timelines.
• Proactively identify potential submission delays and recommend appropriate mitigation measures.

4. Technical Issue Resolution and Operational Support

• Troubleshoot publishing, validation, document-formatting, and submission-related technical issues.
• Collaborate with internal teams, external partners, vendors, and regulatory stakeholders to resolve submission challenges.
• Provide timely operational support during critical submission periods.
• Escalate significant technical or compliance issues to the appropriate stakeholders.
• Support the implementation and maintenance of regulatory publishing systems and tools.

5. Subject Matter Expertise and Knowledge Sharing

• Serve as a Subject Matter Expert for eCTD publishing tools, submission standards, and regulatory publishing best practices.
• Provide technical guidance and support to internal stakeholders.
• Conduct training sessions on publishing processes, submission requirements, and regulatory systems.
• Develop and maintain training materials, standard operating procedures, work instructions, checklists, and user guides.
• Stay updated on changes in global regulatory submission standards and health authority requirements.

6. Documentation and Archive Management

• Maintain complete, accurate, and organized electronic submission archives.
• Ensure appropriate version control, lifecycle documentation, and submission tracking.
• Maintain submission records in Document Management Systems or Regulatory Information Management systems.