Regulatory Documentation Specialist CLIN BIOSCIENCES
CLIN BIOSCIENCES
Office Location
Full Time
Experience: 1 - 1 years required
Pay: INR 600000 - INR 900000 /year
Type: Full Time
Location: Bangalore
Skills: HealthTech, regulatoryaffairs, drugsubmissions, pharmacompliance, regulatoryit, lifesciencesit, Pharma, medicalwriting, regulatorytech
About CLIN BIOSCIENCES
Job Description
Roles and Responsibilities
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Prepare, edit, format, and manage regulatory documents including:
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Clinical study protocols & reports
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Investigator brochures
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Common Technical Documents Modules 25
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Risk Management Plans
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Briefing documents and response packages.
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Work closely with regulatory affairs, clinical, safety, medical writing, and quality assurance teams.
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Maintain version control and document tracking using electronic document management systems.
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Review, QC, and validate documents to ensure scientific accuracy and editorial consistency.
Required Skills:
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Excellent written communication and technical documentation skills.
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Knowledge of regulatory submission processes and eCTD structure.
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Familiarity with global regulatory guidelines.
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Proficiency in MS Word, Adobe Acrobat, and document templates.
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High attention to detail and quality-focused approach.
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Strong organizational and time-management skills .
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Interested to apply can share CV or call/WhatsApp to 9342735755