Regulatory Documentation Specialist CLIN BIOSCIENCES

1.0 - 5.0 years

0 - 0 Lacs

bangalore, chennai, hyderabad

On-site

Roles and Responsibilities Prepare, edit, format, and manage regulatory documents including: Clinical study protocols & reports Investigator brochures Common Technical Documents Modules 25 Risk Management Plans Briefing documents and response packages. Work closely with regulatory affairs, clinical, safety, medical writing, and quality assurance teams. Maintain version control and document tracking using electronic document management systems. Review, QC, and validate documents to ensure scientific accuracy and editorial consistency. Required Skills: Excellent written communication and technical documentation skills. Knowledge of regulatory submission processes and eCTD structure. Familiarit...

Posted 3 months ago

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Regulatory Technology Analyst CLIN BIOSCIENCES

1.0 - 5.0 years

0 - 0 Lacs

hyderabad, united arab emirates, mumbai city

On-site

Roles and Responsibilities Implement and manage Regulatory Information Management Systems and eCTD platforms Automate regulatory submission workflows, ensuring compliance. Work with regulatory affairs teams to manage submission timelines and document lifecycle Configure and support Veeva Vault RIM, Liquent Insight, EXTEDO, or other regulatory platforms Extract, validate, and analyze structured data from submissions and global regulatory databases Assist in audit readiness, quality assurance, and compliance tracking Coordinate with IT and compliance teams for system upgrades, validations, and user training Monitor global regulatory changes and ensure systems are aligned to evolving requiremen...

Posted 3 months ago

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