Regulatory Documentation Specialist @ Clin Biosciences

Job Description

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.

  • Familiarity with global regulatory guidelines.

  • Proficiency in MS Word, Adobe Acrobat, and document templates.

  • High attention to detail and quality-focused approach.

  • Strong organizational and time-management skills .

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