Regulatory Affairs Specialist - KSA

Overview

Regulatory Affairs Specialist - KSA Company : Servier Location : Riyadh, Saudi Arabia Type : Full-time Employment / Unlimited Date posted : Sep 10, 2025 Role Responsibilities

Life-Cycle management of products Pre-registration coordination with WRA and preparation of documentation for KSA to compile product and manufacturing site files, review / preparation / submission of dossiers, fees, inquiries, answers to questions, approvals Life-cycle management of products including new registrations, renewals / minor variations of products and sites Follow country-specific procedures and SFDA guidelines in the KSA market Coordination and liaison with WRA teams / distributors for preparation of all types of regulatory dossiers and local documentation Preparation of price forms and related documentation for new product registration files Liaising with WRA, agents and authorities for documentation submission and follow-up Monitor the registration status of products (submission, registration, expiry dates) Closely collaborate with the Head of the Department for all regulatory tasks Monthly Reports, Correspondences / Mails, Scientific Office Renewal at the SFDA Active involvement in budget preparation for KSA Regulatory Affairs Follow-up on regulatory guidelines and sharing regulatory information with all concerned Reference standard submissions to the authorities Assist the Supply Chain Department with tenders – preparation of documentation for institutional tender submissions Actively involved in Regulatory Audits Regulatory Site Management : For all activities related to KSA - WRA Portal, Ereca, Solaris, LSRIMS, Cosac Other Related Tasks : Managing / organizing department-supported conferences for Health Authorities in the ME, liaising with agents and Health Authorities in KSA, responsible for Change Controls for Variations in the ME region, deputy for local responsible person for advertisement / promotional material, deputy for validation of packaging items, cross-collaboration with other ME departments Dimensions : Geographical span ME - KSA; work with ME Regulatory Lead to understand regulatory guidelines and technical requirements in KSA; life cycle management and compliance; cross-functional support; report to Head of Department Requirements

Educational qualifications : Bachelor’s Degree in Pharmacy / Science Relevant Experience : 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization; experience in Saudi Arabia preferred; experience in a Global pharmaceutical company is advantageous Skills & Personal Characteristics : Good knowledge of the Regulatory environment and procedures in KSA; strong regulatory intelligence; ability to work cross-functionally; strategic thinker, innovative, able to drive multiple initiatives; ability to work under pressure; team player; multitasking, organized, process- and result-oriented; excellent interpersonal, negotiation and relationship-building skills; excellent communication and digital skills; fluent in English and Arabic (French is an added advantage) We’re committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit — all focused on your well-being. At Servier, we are dedicated to advancing therapeutic progress to serve patient needs. EEO statement : We are an equal opportunity employer. Referrals increase your chances of interviewing at Servier by 2x.

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