Quality Assurance-Regulatory Affairs/Executive -Laison

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: Can send to email to hr@qpsbioserve.com

Perks and benefits: Nil