Regulatory Affairs Executive

Protectol Health; Dammam; On-site; SAR 200,000 - 300,000; Full time

Job summary

A leading healthcare company in Dammam is seeking a Regulatory Affairs professional to manage SFDA submissions and ensure compliance with regulations. Candidates should hold a degree in pharmacy or Life Sciences and possess 1–4 years of relevant experience, particularly in the KSA market. This role is exclusively open to Saudi nationals and offers opportunities for team leadership. Attractive benefits are included.

Qualifications

• At least 1–4 years of experience in Regulatory Affairs within the pharmaceutical sector.
• Strong experience in SFDA submission processes.
• Proven track record in handling product variations.

Responsibilities

• Prepare accurate responses to SFDA inquiries.
• Review variation submissions and classifications.
• Compile and submit eCTD dossiers for products.

Skills

Regulatory compliance

SFDA submission processes

eCTD compilation

Product variations management

Team management

Education

Bachelor’s or master’s degree in pharmacy or Life Sciences

Job description

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.