Regulatory Affairs Executive: SFDA & eCTD Specialist

Protectol Health; Dammam; On-site; SAR 80,000 - 120,000; Full time

Job summary

A healthcare organization in Dammam is seeking a Regulatory Affairs Specialist. The role requires Saudi nationals with a degree in pharmacy or Life Sciences and 1–4 years of experience in the pharmaceutical or healthcare sector, specifically in the KSA market. Key responsibilities include managing SFDA inquiries, compiling regulatory submissions, and maintaining product registrations. This position will also involve developing relationships with regulatory officials to ensure compliance and support audits.

Qualifications

• Open exclusively to Saudi nationals.
• Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, with at least 1 year in the KSA market.
• Strong experience in SFDA submission processes and regulations.
• Proven track record in handling product variations, renewals, and regulatory compliance.

Responsibilities

• Prepare accurate and timely responses to SFDA inquiries.
• Review and analyze variations from internal departments.
• Compile, validate, and submit eCTD dossiers for medicinal products.
• Monitor and follow up on regulatory submissions with SFDA.
• Ensure successful execution of the product registration plan.
• Maintain valid registration of products in the market.
• Act as the regulatory liaison for product life cycle activities.
• Develop strong relationships with SFDA officials.
• Support audits and inspections.

Education

Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field

Tools

eCTD compilation and publishing

Job description

A healthcare organization in Dammam is seeking a Regulatory Affairs Specialist. The role requires Saudi nationals with a degree in pharmacy or Life Sciences and 1–4 years of experience in the pharmaceutical or healthcare sector, specifically in the KSA market. Key responsibilities include managing SFDA inquiries, compiling regulatory submissions, and maintaining product registrations. This position will also involve developing relationships with regulatory officials to ensure compliance and support audits.