Quality Assurance-Regulatory Affairs/Executive

QPS Bioserve

2 - 4 years

3 - 5 Lacs

hyderabad

Posted:6 days ago| Platform:

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Skills Required

regulatory affairs ich-gcp guidelines quality check clinical trials dcgi quality audit fda anda nda benoc standard operating procedures cdsco

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities:

To Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data.
To search for submission documents, understanding the regulatory requirements and provide the documents.
Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence.
Preparation of audit reports and suitable corrective and preventive action plans.
To review Standard Operating Procedures to check for compliance with regulatory requirements.
To have experience in the Ethics Committee related activities.
To liaison with DCGI/CDSCO for regulatory approvals for conducting BA/BE clinical studies in India.
Timely notification to DCGI//CDSCO for study related updates
To search literature on healthy population to support BA/BE NOC application
To liaise CBN for regulatory approvals for conducting clinical studies in India.
To coordinate with global regulatory authorities for regulatory strategic for various products and services
Proactive co-ordination of all the necessary activities required regulatory submission.

Preferred candidate profile:

Perks and benefits: Nil

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