Regulatory Affairs Manager – Saudi National

Regulatory Affairs Manager – Saudi National

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Job Scope

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.

Job 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

Mid-Senior level

Employment type

Full-time

Job function

Product Management, Quality Assurance, and Distribution

Industries

Pharmaceutical Manufacturing and Hospitals and Health Care

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