Regulatory Affairs Executive

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

Key Responsibilities

• Prepare accurate and timely responses to SFDA inquiries in coordination with relevant departments, ensuring compliance with applicable regulations and deadlines.
• Review and analyze variations received from internal departments, determine their classification (major/minor), assess required documents, and prepare variation submissions in line with SFDA guidelines.
• Compile, validate, and submit eCTD (electronic Common Technical Document) dossiers for medicinal products and herbal/health supplements.
• Monitor and follow up on regulatory submissions, price appeals, inquiries, and variation statuses with SFDA to ensure process continuity and timely approvals.
• Ensure successful execution of the product registration plan, tracking milestones and collaborating with internal stakeholders to meet objectives.
• Maintain valid registration of all products in the market, ensuring that PILs (Patient Information Leaflets), SmPCs (Summary of Product Characteristics), and artworks are continuously updated and compliant.
• Act as the regulatory liaison for product life cycle activities, post-approval changes, and renewals to support product continuity in the KSA market.
• Stay abreast of changes in local regulations and provide strategic input to management on anticipated regulatory risks or opportunities.
• Develop and maintain strong relationships with SFDA officials and regulatory consultants to support proactive and smooth regulatory interactions.
• Support audits and inspections by ensuring readiness of regulatory documentation and compliance records.

Qualifications

• This position is open exclusively to Saudi nationals.
• Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.
• Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, with at least 1 years in the KSA market.
• Strong experience in SFDA submission processes and regulations.
• Hands‑on experience with eCTD compilation and publishing.
• Proven track record in handling product variations, renewals, and regulatory compliance.
• Prior experience in managing or mentoring a small team is preferred.