Compile and publish electronic regulatory submissions using publishing tools like Lorenz DocuBridge, Veeva Vault, and Extedo.
Ensure compliance with eCTD standards, including bookmarks, hyperlinks, metadata, and validation.
Perform quality control checks on submission components and final packages.
Collaborate with cross-functional teams to gather and finalize documents.
Maintain submission archives and ensure version control and traceability.
Stay current with global regulatory guidelines and publishing best practices.
Support audits and inspections by ensuring documentation integrity and readiness.
Troubleshoot formatting and technical issues in submission documents and contribute to process improvements and publishing workflow optimization.

Job Requirements

Graduate or Postgraduate degree in Pharmacy, Life Sciences, or a related field.
Proficiency in publishing software such as Lorenz DocuBridge, Veeva Vault, and Extedo.
Strong knowledge of eCTD structure, regional submission formats, and validation tools.
Adequate knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA & Global Health authority regulations).
Excellent communication, collaboration, presentation, and stakeholder management skills.
Strong analytical, attention to detail, and problem-solving abilities.
Stable track record in the LS Regulatory domain within a mid-large organization.
Proficiency in MS Office, regulatory work processes, and good knowledge of Global Regulatory submission requirements especially USFDA, MHRA, EMA, APAC, GCC, LATAM for Medical Devices and/or Medicinal/Biotech products.
Familiarity with Microsoft Word, Adobe Acrobat, and document formatting standards is required.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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