Overview
Regulatory Affairs Associate Jobs in Doha at International Medical Company
Description
Assist in the preparation, review, and submission of regulatory documentation to ensure compliance with applicable regulations. Involves handling specific regulatory tasks, interacting with regulatory agencies, supporting multiple principals, and managing simple regulatory dossiers. Collaborates with internal teams and external partners to facilitate timely approvals and compliance.
- Prepare, review, and submit regulatory dossiers (registration, renewal, and variations) to MOPH.
- Submit files considering urgency, partner priorities, and IMC priorities.
- Submit dossiers via MOPH’s online system and ensure timely physical submissions of hard copies.
- Review received dossiers in detail to ensure completeness based on the application type.
- Follow up with MOPH on submitted dossier status and communicate inquiries to partner companies.
- Maintain registrations, renewals, and minor variations for Marketing Authorization Holders, Manufacturers, Herbs, and Food Supplements.
- Consult and communicate with partner companies regarding file readiness, request missing documents, and provide submission timelines.
- Coordinate with partners to obtain required documents to complete dossiers.
- Follow up with the MOPH release department to obtain final release of shipments.
- Receive files through IMC reception, check accuracy of documents/samples/CDs, and send confirmation or request missing items
- Review registration certificates of registered products/companies and notify partners regarding renewals according to MOPH.
- Compile and maintain regulatory documentation databases and systems.
- Review and interpret new registration requirements for herbal products and food supplements.
- Monitor regulatory changes and inform management and quality teams about updates that may impact SOPs.
- Follow up on Pharmacovigilance activities and submission of safety updates
- Support audits, inspections, and compliance reviews.
- Assist in the review of product labels, leaflets, and promotional materials for compliance.
- Stay updated with changes in local and regional regulations.
Requirements
- B.Sc. degree in Pharmacy, Chemistry, Biology, or related discipline.
- Min 1 year of regulatory affairs experience (internships or fresh graduates may be considered).
- Knowledge of GCC and Qatar regulatory processes preferred.
- Strong organizational skills, attention to detail, and ability to work under deadlines.
- Problem-solving skills with adaptability and scientific acumen.
- High-level proficiency in English (writing and speaking); Arabic is an advantage.
- Very good MS Office skills (Word, Excel, PDF, etc.).
Pay: QAR4,000.00 – QAR5,000.00 per month
Work Location: In person
Title: Regulatory Affairs Associate
Company: International Medical Company
Location: Doha
