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
- Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.
- Minimum 6–8 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, with at least 3 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.