Regulatory Affairs Associate MENA

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

The Regulatory Affairs Associate supports Regulatory Affairs activities across the MENA region with primary focus on Saudi Arabia This junior role supports regulatory submissions maintenance of product registrations and compliance with local Health Authority requirements The position contributes to ensuring timely approvals and lifecycle management of products under supervision of Head of Regulatory Affairs

Key Responsibilities

• Support preparation compilation and submission of regulatory dossiers new registrations variations renewals for Saudi Arabia and MENA countries
• Assist in tracking submission timelines approvals and regulatory commitments
• Support lifecycle management activities for registered products
• Maintain and update regulatory databases and trackers e g submission status HA queries
• Liaise with internal Regional amp global stakeholders Quality Pharmacovigilance Supply Chain Commercial to collect required regulatory documents
• Support responses to Health Authority queries under guidance of senior RA staff
• Ensure regulatory documents are archived in compliance with internal procedures and eDMS requirements
• Support implementation of regional regulatory projects and digitalization initiatives
• Performs other duties as assignedReporting amp ComplianceReport Adverse Drug Reactions ADRs and Complaints about Fresenius Kabi s products from Market Unit MENA to the responsible function i e EMAIL ADDRESS-kabi com immediately after receipt but latest within 1 business day

Qualifications

• Bachelor s degree in Pharmacy.
• Saudi National with 1 2 years of experience in Regulatory Affairs, preferably within Multinational company
• Understanding of Saudi FDA (SFDA) regulatory requirements is a must.
• Experience in regulatory documentation and submission processes In other MENA countries.
• Strong attention to detail and good organizational skills.
• High level of integrity and ability to maintain confidentiality
• Good written and verbal communication skills.
• Ability to work collaboratively in a cross-functional and multicultural environment.
• Basic MS Office proficiency (Word, Excel, PowerPoint).
• Ability to manage multiple tasks and meet deadlines.
• Willingness to learn and develop regulatory expetise.
• High level of integrity and ability to maintain confidentiality.