Regulatory Officer - IVD

About the role

A company is looking for a detail-oriented Regulatory Officer for in vitro diagnostics (IVD) to manage regulatory affairs, DRAP submissions, product registration, import documentation and compliance for IVD products. The ideal candidate holds a Doctor of Pharmacy (Pharm-D) degree with 1-2 years of relevant experience in the diagnostics or IVD industry; hands-on experience with DRAP submissions, IVD registration and import clearance is preferred.

Key responsibilities

• Prepare and manage DRAP applications for IVD product registration, enlistment, import permissions, renewals and other regulatory approvals.
• Handle document uploads, challan generation, application tracking and correspondence through DRAP e-Portals.
• Coordinate with international principals and suppliers for technical documents, product specifications, certificates and other regulatory documentation.
• Follow up on DRAP queries and ensure timely submission of responses and supporting documents.
• Prepare and verify import documentation (COA, COO, invoices, packing lists, Form-1, Form-11, PER) and coordinate with customs agents, principals, suppliers and logistics teams for clearance.
• Track import consignments and maintain accurate records in line with DRAP requirements.
• Maintain regulatory files, product dossiers, registration certificates and compliance records, and support regulatory inspections and audits.
• Monitor product registration validity, renewal timelines and changes in regulatory requirements.

Required profile

• Doctor of Pharmacy (Pharm-D) or Biomedical Engineering degree.
• 1-2 years of relevant experience specifically in the diagnostics or IVD industry; candidates with only pharmaceutical experience will not be considered.
• Working knowledge of DRAP regulations and IVD product registration requirements.
• Strong documentation, communication, coordination and organisational skills.

Required skills

• Practical experience with DRAP e-Portals, regulatory submissions and import documentation preferred.
• Proficiency in Microsoft Office, particularly Word and Excel.