Regulatory Affairs -Liasoning

Role & responsibilities:

• Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions).

• Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations.

• Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on.

• Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data.

• 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 have experience in the Ethics Committee related activities.

• To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India.

• Timely notification to DCGI/CDSCO for study related updates

• Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions.

• Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies.

• 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:

• Education: Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred).

• Experience: 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role.

• Knowledge: In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes.

Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com