Experience Required: 3–8 Years
Department: Regulatory Affairs
Reporting To: Regulatory Operations Manager / Head – Regulatory Affairs
About the Role
We are looking for an experienced and detail-oriented Regulatory Publishing Specialist to support the preparation, compilation, publishing, validation, submission, archiving, and lifecycle management of global regulatory submissions.
The role involves working with eCTD publishing tools such as DocuBridge and Lorenz and ensuring that regulatory submissions comply with applicable requirements of FDA, EMA, ICH, and other global regulatory agencies.
The ideal candidate should have strong technical knowledge of regulatory publishing and submission standards, excellent attention to detail, strong troubleshooting skills, and the ability to coordinate effectively with cross-functional teams to deliver high-quality submissions within defined timelines.
Key Responsibilities
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 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.
eCTD Compliance & Quality Management
Ensure regulatory submissions comply with FDA, EMA, ICH, and 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.
Submission Planning & 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.
Technical Issue Resolution & 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 appropriate stakeholders.
Support the implementation and maintenance of regulatory publishing systems and tools.
Subject Matter Expertise & Knowledge Sharing
Serve as a Subject Matter Expert (SME) 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, SOPs, work instructions, checklists, and user guides.
Stay updated on changes in global regulatory submission standards and health authority requirements.
Documentation & 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.
Support audit readiness and regulatory inspection preparedness.
Ensure submission documents and records are maintained in accordance with applicable retention requirements.
Process Mapping & Continuous Improvement
Create, review, and maintain process maps for regulatory publishing and submission activities.
Identify opportunities for process standardization, optimization, and automation.
Support the development and implementation of publishing templates, tools, and quality-control mechanisms.
Ensure controlled documentation and effective version-management practices.
Participate in continuous improvement initiatives to enhance submission quality, efficiency, and compliance.
Required Skills & Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Biological Sciences, or a related discipline.
Postgraduate qualification or certification in Regulatory Affairs will be preferred.
3–8 years of relevant experience in Regulatory Operations or Regulatory Publishing.
Hands-on experience with DocuBridge, Lorenz, eValidator, or equivalent regulatory publishing and validation tools.
Experience in preparing and publishing FDA, EMA, and other global eCTD submissions.
Experience with initial applications, lifecycle submissions, variations, supplements, annual reports, renewals, and regulatory responses.
Experience with Document Management Systems or Regulatory Information Management systems will be preferred.
Technical Skills
eCTD publishing and submission lifecycle management.
Knowledge of ICH, FDA, EMA, and regional electronic submission standards.
Hands-on proficiency in DocuBridge, Lorenz, or equivalent publishing tools.
Experience with submission validation tools such as eValidator.
Knowledge of PDF preparation, hyperlinking, bookmarking, metadata, and document formatting.
Proficiency in Microsoft Office applications.
Working knowledge of Document Management Systems and Regulatory Information Management systems.
Key Competencies
Strong attention to detail and commitment to quality.
Effective project coordination and submission-planning skills.
Strong analytical, problem-solving, and troubleshooting abilities.
Effective stakeholder communication and collaboration skills.
Ability to manage multiple submissions and priorities simultaneously.
Strong time-management skills and deadline orientation.
Ability to perform effectively during critical submission periods.
Continuous learning and process-improvement mindset.
Ability to work independently as well as collaboratively within cross-functional teams.
Job Features
Department: Regulatory Affairs
Experience: 3–8 Years
Role: Regulatory Publishing Specialist
Apply Online
Interested candidates who meet the above requirements are encouraged to apply by submitting their updated CV through the application form.
Email us: Career@ddreg.in