Regulatory Affairs Lead

3 days ago


Ahmedabad, Gujarat, India Search Advisers Services Guj Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities

Need sound knowledge of domestic regulatory functions with ref to DBT-RCGM, CDSCO and state FDA regulations.

Will prepare and submit dossier to RCGM for approval of PCT application to dept of

Biotechnology

Review and timebound submission of application for MAA, PAC, CT (Phase I, II and Phase III

applications),

Responsible for IBSC meeting conduction and related regulatory activities.

Preferred candidate profile

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