Regulatory Affairs and Pack & Artwork Manager

About the Role

GSK Saudi Arabia is dedicated to supporting the country's Vision 2030 and promoting Saudization through hiring and development of Saudi nationals. The Regulatory Affairs & Artwork Manager leads the management of packaging and artwork for pharmaceuticals and vaccines distributed within Saudi Arabia. This role bridges regulatory affairs, supply chain, quality, marketing, and medical teams to ensure compliance with both the Saudi Food & Drug Authority (SFDA) requirements and global GSK standards, delivering accurate regulatory submissions and high-quality artwork.

Key Responsibilities

• Manage the entire packaging and artwork process for medicines and vaccines delivered to Saudi Arabia, ensuring that labeling and artwork adhere to approved product information and local regulatory guidelines.
• Coordinate and review artwork briefs, amendments, and checks; approve final artwork in the designated system, confirming all necessary components are correctly updated.
• Design and implement submission strategies covering new registrations, variations, renewals, and labeling updates, achieving first-time approval and adherence to SFDA regulations and GSK SOPs.
• Maintain thorough regulatory documentation, including registration dossiers, variations, renewals, labeling, and artwork files, within appropriate regulatory platforms and archives.
• Serve as the Quality Management System (QMS) lead for packaging and artwork control, ensuring team training, compliance with global and local procedures, and prompt completion of audit and inspection action items.
• Coordinate activities related to the regulatory risk register such as quarterly evaluations, risk identification, and monitoring mitigation efforts, working with internal teams and external authorities to resolve issues and promote ongoing improvements.

Qualifications

• Must be a Saudi national.
• Possess a Bachelor's degree in Pharmacy.
• Hold a valid SCFHS license as a certified pharmacist in Saudi Arabia.
• Have at least five years of pharmaceutical industry experience with a minimum of three years specifically in Regulatory Affairs.
• Demonstrated strong knowledge of SFDA regulations and regulatory submission processes including variations and renewals.
• Bilingual proficiency in Arabic and English, with excellent written and verbal communication skills in both languages.

Preferred Skills and Experience

• Familiarity with pharmaceutical artwork and pack management workflows and systems.
• Experience using artwork control software (such as design and review tools) and regulatory documentation platforms or electronic vaults.
• Excellent organizational, time-management, and stakeholder engagement skills to manage hybrid responsibilities across regulatory and artwork functions.

Additional Information

GSK is an Equal Opportunity Employer committed to providing equal employment opportunities without discrimination on any legally protected basis including race, religion, gender identity, sexual orientation, national origin, disability, military status, and more. The company values a workplace where all employees can thrive and contribute to advancing health globally through innovation in specialty medicines and vaccines.

Applicants must be Saudi nationals compliant with Saudi Vision 2030 objectives.

Employment agencies must have prior written consent from GSK to submit candidates; unauthorized referrals will not be accepted or remunerated.