Regulatory Officer – IVD

Global Marketing Services, Pakistan · Saddar, Pakistan

Regulatory Officer – IVD

About the Job

We are looking for a detail-oriented Regulatory Officer – IVD (In Vitro Diagnostics) to manage regulatory affairs, DRAP submissions, product registration, import documentation, and compliance for in-vitro diagnostic products.

The ideal candidate must hold a Doctor of Pharmacy (Pharm-D) degree with 1–2 years of relevant experience specifically in the diagnostics or IVD industry. Candidates with hands-on experience in DRAP submissions, IVD product registration, and import clearance procedures will be preferred.

Key Responsibilities

IVD Product Registration & DRAP Submissions

• Prepare and manage DRAP applications for IVD product registration, enlistment, import permissions, renewals, and other applicable regulatory approvals.
• Handle document uploads, challan generation, application tracking, and correspondence through DRAP e-Portals.
• Coordinate with international principals and suppliers to obtain technical documents, product specifications, certificates, and other regulatory documentation.
• Follow up on DRAP queries and ensure timely submission of responses and supporting documents.

Import & Consignment Clearance

• Prepare and verify import documentation, including COA, COO, invoices, packing lists, Form-1, Form-11, PER, and other applicable documents and approvals.
• Coordinate with customs agents, principals, suppliers, and logistics teams to facilitate timely clearance of IVD products and diagnostic equipment.
• Track import consignments and maintain accurate records in accordance with applicable DRAP requirements.

Regulatory Compliance & Documentation

• Maintain regulatory files, product dossiers, registration certificates, and compliance records for the IVD portfolio.
• Ensure compliance with applicable DRAP regulations, medical device requirements, and internal company SOPs.
• Support regulatory inspections and audits by providing the required documentation.
• Monitor product registration validity, renewal timelines, and changes in applicable regulatory requirements.

Qualifications & Skills

• Education: Doctor of Pharmacy (Pharm-D) – mandatory.
• Experience: 1–2 years of relevant experience specifically in the diagnostics or IVD industry.
• Working knowledge of DRAP regulations and IVD product registration requirements.
• Practical experience with DRAP e-Portals, regulatory submissions, and import documentation will be preferred.
• Strong documentation, communication, coordination, and organizational skills.
• Proficiency in Microsoft Office, particularly Word and Excel.

Important: Candidates with experience exclusively in the pharmaceutical industry, without relevant diagnostics or IVD industry experience, will not be considered.