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Regulatory Affairs Manager – Saudi National
Confidential JobsRiyadh, Riyadh Region, Saudi Arabia5 منذ أيام
الوصف الوظيفيBachelor’s degree in Pharmacy (BPharm) is mandatory (Master’s preferred). 7+ years of regulatory affairs experience in the pharmaceutical industry, including strong exposure to the KSA market. Proven record of successful SFDA product registrations and renewals. Deep knowledge of KSA pharmaceutical laws, pricing policies, and compliance frameworks. Strong communication and stakeholder management skills. Fluency in English & Arabic Mid-Senior level Full-time Product Management, Quality Assurance, and Distribution Pharmaceutical Manufacturing Hospitals and Health Care
Overview
Regulatory Affairs Manager to oversee and manage all regulatory activities for pharmaceutical products in the Kingdom of Saudi Arabia. The role ensures full compliance with SFDA regulations and supports business growth by securing timely approvals and renewals for our portfolio.
Responsibilities
- Manage product registration, renewal, and variations with the SFDA.
- Ensure compliance with SFDA guidelines covering pricing, labeling, and packaging.
- Prepare, review, and submit complete regulatory dossiers.
- Liaise with SFDA officials to resolve queries and secure approvals.
- Monitor changes in KSA pharmaceutical regulations and update management on implications. Support B2B partnerships by providing regulatory expertise for new product launches.
- Maintain accurate regulatory documentation for audits and inspections.
- Provide training and guidance to internal teams on SFDA compliance processes.
Requirements
Seniority level
Employment type
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Manager Saudi National • Riyadh, Riyadh Region, Saudi Arabia