Regulatory Officer – IVD

Global Marketing Services, Pakistan

Rawalpindi , Pakistan

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Posted 2 days ago 30 views Report Job

We are seeking a detail-oriented Regulatory Officer specializing in In Vitro Diagnostics (IVD) to oversee regulatory affairs related to product registration, DRAP submissions, import documentation, and compliance management for IVD products. The role requires managing the entire regulatory process, including preparing applications, coordinating with international suppliers, and ensuring adherence to DRAP regulations. The ideal candidate will have a Doctor of Pharmacy (Pharm-D) degree and 1–2 years of relevant experience within the diagnostics or IVD industry, with hands-on expertise in DRAP submissions and import clearance procedures.

Key Responsibilities

IVD Product Registration & DRAP Submissions
- 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 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 such as Certificates of Analysis (COA), Certificates of Origin (COO), invoices, packing lists, Form-1, Form-11, PER, and other necessary approvals.
- Liaise 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 compliance with DRAP requirements.

Regulatory Compliance & Documentation
- Maintain regulatory files, product dossiers, registration certificates, and compliance records for the IVD product portfolio.
- Ensure compliance with applicable DRAP regulations, medical device requirements, and internal company Standard Operating Procedures (SOPs).
- Support regulatory inspections and audits by providing required documentation.
- Monitor product registration validity, renewal timelines, and stay updated on changes in regulatory requirements.

Required Qualifications
- Doctor of Pharmacy (Pharm-D) degree is mandatory.
- 1–2 years of relevant experience specifically in the diagnostics or IVD industry.
- Working knowledge of DRAP regulations and IVD product registration requirements.
- Strong documentation, communication, coordination, and organizational skills.
- Proficiency in Microsoft Office applications, especially Word and Excel.

Preferred Qualifications and Additional Information
- Practical experience with DRAP e-Portals, regulatory submissions, and import documentation is highly preferred.
- Candidates with experience solely in the pharmaceutical industry without relevant diagnostics or IVD exposure will not be considered.

This position offers the opportunity to work in a specialized regulatory role within the growing field of in vitro diagnostics, contributing to the successful registration and compliance of critical medical products.