Medical & Regulatory Writer
Year Ahmedabad, Gujarat, India
Job Description
- Ensure clinical investigations comply with ISO 14155:2020 and ICH-GCP guidelines.
- Oversee regulatory submissions and study approvals in alignment with the New Drugs and Clinical Trials Rules (NDCTR), 2019.
- Coordinate biocompatibility evaluations following ISO 10993-1 requirements.
- Support risk management activities as per ISO 14971 and ISO 24971.
- Prepare and maintain clinical study documentation, protocols, and reports.
- Conduct internal audits and compliance checks to ensure adherence to global and local regulatory standards.
- Collaborate with clinical teams, regulatory authorities, and ethical committees for study execution and approvals.
- Provide training on clinical compliance, regulatory updates, and quality system requirements.
Skills Required
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Job Detail
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Job IdJD4829361
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear