Regulatory Affairs & Pack & Artwork Manager

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

GSK السعودية ملتزمة بدعم رؤية 2030 والأجندة الوطنية للمملكة العربية السعودية، بما في ذلك مبادرات التوطين، وذلك بما يتماشى مع تعيين وتدريب وتطوير الكفاءات الوطنية السعودية.

The RA & Artwork Manager is responsible for leading pack management and artwork control for medicines and vaccines supplied to Saudi Arabia, while owning key Regulatory Affairs activities across submissions, product lifecycle management and labelling. This hybrid role acts as a central link between Regulatory Affairs, Supply, Quality, Marketing and Medical, ensuring compliant, right‑first‑time regulatory outputs and high‑quality artwork in line with SFDA regulations and GSK global standards.

• Own end‑to‑end pack management and artwork control for medicines and vaccines supplied to Saudi Arabia, ensuring labelling and artwork content comply with approved product information and local regulatory requirements.
• Coordinate and review artwork briefs, annotations and checks, and approve final artwork in the artwork system against source documentation, ensuring all impacted components are accurately updated.
• Develop and execute submission strategies for new registrations, variations, renewals and labelling updates, securing right‑first‑time submissions and timely approvals in line with SFDA guidelines and GSK SOPs.
• Maintain robust regulatory documentation and records (including registration dossiers, variations, renewals, labelling and artwork files) in relevant regulatory systems and vaults.
• Act as QMS champion for pack management and artwork control, ensuring training, compliance with global and local SOPs, and effective closure of audit and inspection actions.
• Facilitate regulatory risk register activities (e.g. quarterly reviews, risk identification, mitigation tracking) and collaborate with internal stakeholders and external authorities to resolve issues and drive continuous improvement.

• Saudi National.
• Bachelor’s degree in pharmacy.
• A valid SCFHS license as a certified pharmacist in Saudi Arabia.
• Minimum 5 years’ experience in the pharmaceutical industry, including at least 3 years in Regulatory Affairs.
• Strong knowledge of SFDA regulations and regulatory systems, with experience in submissions, variations and renewals.
• Bilingual (Arabic and English), with strong written and verbal communication skills in both languages.

• Experience in artwork and pack management processes and systems within a pharmaceutical environment.
• Working knowledge of artwork control tools (e.g. design and review software) and regulatory documentation platforms or vaults.
• Strong time management, organization and stakeholder‑management skills, with the ability to lead hybrid responsibilities across regulatory and artwork functions.