Regulatory Affairs Job at Veeda Lifesciences – Apply Online Only at Biotecnika

Regulatory Affairs Job at Veeda Lifesciences – Apply Online Only at Biotecnika

Veeda Clinical Research Ltd.

Biopharmaceutics Regulatory Affairs Job – Veeda Lifesciences

JOB DESCRIPTION

Functional Role: Regulatory Affairs

Qualification: MSc., B.Pharm, M.Pharm, Pharm.D (RA)

CTC: 2.5 LPA – 6 LPA

Location: Ahmedabad

Primary Responsibility

Evaluation & Regulatory Compliance: Ensure compliance with domestic and international regulatory norms for BA/BE and clinical trials during feasibility. Conduct literature reviews and advise teams on non-conventional studies. Verify initial regulatory approvals, process online regulatory fee payments, and oversee facility-related approvals.

Planning & Budgeting: Consult with seniors to plan and assign feasibility studies and regulatory applications, assess budget needs for compliance, and submit annual reports to superiors.

Liaisoning: Coordinate and follow up with regulatory authorities via email, phone, or visits for study approvals within timelines. Update and consult superiors (PM) to expedite approvals.

Communication & Review: Communicate regulatory updates affecting feasibility/study to departments and sponsors after consulting superiors. Review, ensure compliance, and provide feedback on study documents while coordinating with sponsors through the PM.

Documentation: Prepare and submit approved applications to regulatory authorities (CDSCO, Central Bureau of Narcotics, local FDCA) within the defined timeframe. Track import/export status of controlled substances and submit monthly reports to the Central Bureau of Narcotics, Gwalior.

MIS:

Regularly update the Regulatory Application Status MIS and submit it to management after consulting superiors. Prepare a monthly reconciliation of regulatory fees, get approvals from PM & HoD, and submit it to F&A. Handle additional tasks as assigned.

The Last Date to Apply- 04th March 2025 (Tuesday) at 10 AM

APPLY ONLINE HERE

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