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 5 months ago

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External Affairs Analyst- Healthcare CLIN BIOSCIENCES

2.0 - 5.0 years

0 - 0 Lacs

mumbai city, united arab emirates, qatar

On-site

We are seeking a strategic and detail-oriented External Affairs Analyst-Healthcare to support our organizations engagement with external stakeholders including government bodies, regulatory authorities, healthcare policymakers, and industry associations. Roles and Responsibilities Track and analyze healthcare legislation, government policy updates, and regulatory changes. Assist in shaping and delivering the organizations external engagement strategy. Draft policy briefs, position statements, and regulatory impact assessments. Liaise with government officials, public health bodies, and industry associations. Provide strategic recommendations on healthcare policies affecting business operatio...

Posted 5 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...

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