Regulatory Affairs Officer

Based in Karachi, the Regulatory Affairs Officer plays a vital role in ensuring that all company products comply with DRAP regulations and supporting the regulatory submission process. This position involves managing and maintaining essential documentation related to tenders and commercial operations, while working closely with internal teams and external stakeholders to facilitate smooth regulatory activities. Reporting directly to the Regulatory Affairs Manager, the officer will help uphold high compliance standards and provide assistance during audits and inspections.

Key Responsibilities
- Prepare and submit product registrations, renewals, variations, and import permissions to DRAP in a timely and accurate manner.
- Maintain and organize all regulatory documents, including certificates, technical files, Instructions for Use (IFUs), and CEO declarations, ensuring they are up to date and easily accessible.
- Support tender submissions by compiling and providing updated DRAP certificates, import history, and compliance forms as required.
- Coordinate regulatory requirements and communications with principals and manufacturers to ensure alignment with local regulations and company policies.
- Assist Sales and Procurement teams by providing regulatory status updates to facilitate institutional approvals and import planning.
- Ensure compliance with Good Distribution Practices (GDP) and actively support audits and inspections by preparing necessary documentation and responding to queries.

Required Qualifications
- A degree in Pharm-D, Biomedical Sciences, or Life Sciences.
- Between 1 to 3 years of relevant experience in regulatory affairs or a related field.
- Solid knowledge of DRAP regulations and Medical Devices Rules 2017 is essential for this role.

Skills
- Strong documentation and communication skills to effectively manage regulatory submissions and liaise with various stakeholders.
- Proficiency in MS Office applications for documentation, reporting, and record-keeping purposes.
- Detail-oriented with excellent organizational skills to maintain accurate and comprehensive regulatory records.

This is a full-time, in-person position based in Karachi, offering a valuable opportunity to work in a dynamic regulatory environment. The role supports healthcare product compliance and market access, contributing to the company’s commitment to quality and regulatory excellence.