Regulatory Affairs Associate, MENA — Saudi Submissions

Fresenius Kabi; Riyadh; On-site; SAR 60,000 - 90,000; Full time

Job summary

Fresenius Kabi is seeking a Regulatory Affairs Associate to support regulatory activities across the MENA region, with a primary focus on Saudi Arabia. This junior role covers submissions, registration maintenance, and compliance under supervision of the Head of Regulatory Affairs.

You will assist in dossier preparation, tracking timelines, and liaising with regional and global stakeholders to ensure timely approvals and lifecycle management for registered products.

Qualifications

• Bachelor's degree in Pharmacy is required.
• Saudi National with 1–2 years in Regulatory Affairs.
• Understanding SFDA/regulatory requirements is essential.
• Experience with regulatory documentation and submissions in MENA is preferred.
• Strong attention to detail and organizational skills.
• High integrity and ability to handle confidential information.

Responsibilities

• Assist in preparation, compilation and submission of regulatory dossiers for Saudi Arabia and MENA.
• Track submission timelines, approvals and regulatory commitments.
• Support lifecycle management for registered products.
• Maintain regulatory databases and trackers; respond to HA queries.
• Coordinate with regional and global stakeholders to gather documents.
• Support regulatory project implementations and digitalization initiatives.
• Archive regulatory documents per procedures and eDMS requirements.

Skills

Regulatory submissions

Attention to detail

Cross-functional collab

Communication skills

Education

Bachelor's degree in Pharmacy

Tools

MS Office

Job description

Fresenius Kabi is seeking a Regulatory Affairs Associate to support regulatory activities across the MENA region, with a primary focus on Saudi Arabia. This junior role covers submissions, registration maintenance, and compliance under supervision of the Head of Regulatory Affairs.

You will assist in dossier preparation, tracking timelines, and liaising with regional and global stakeholders to ensure timely approvals and lifecycle management for registered products.