Position Summary
- Legal Entity: Fresenius Kabi Saudi Arabia / MENA Region
- Location: Riyadh, Saudi Arabia
- Department: Regulatory Affairs & Quality Assurance – MENA Region
- Reporting to : Head of Regulatory Affairs & Quality Assurance - MENA Region
Job Purpose:
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 & Quality assurance.
Responsibilities / Duties:
Key Responsibilities
1. Support preparation, compilation, and submission of regulatory dossiers (new registrations, variations, renewals) for Saudi Arabia and MENA countries.
2. Assist in tracking submission timelines, approvals, and regulatory commitments.
3. Support lifecycle management activities for registered products.
4. Maintain and update regulatory databases and trackers (e.g., submission status, HA queries).
5. Liaise with internal , Regional & global stakeholders (Quality, Pharmacovigilance, Supply Chain, Commercial) to collect required regulatory documents.
6. Support responses to Health Authority queries under guidance of senior RA staff.
7. Ensure regulatory documents are archived in compliance with internal procedures and eDMS requirements.
8. Support implementation of regional regulatory projects and digitalization initiatives.
9. Performs other duties as assigned
Reporting & Compliance
Report Adverse Drug Reactions (ADRs) and Complaints about Fresenius Kabi’s products from Market Unit MENA to the responsible function, i.e., mena.vigilance@fresenius-kabi.com, immediately after receipt, but latest within 1 business day.
Competence Requirements:
- 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.
Required Skills:
- 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.