Regulatory Affairs & Pack & Artwork Manager
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Key skills for this role
About the Role
Responsible for pack management and artwork control, ensuring compliance with SFDA regulations, while managing submissions and documentation in a bilingual environment.
Key Skills for This Role
Responsibilities
- Own end to end pack management and artwork control for medicines and vaccines supplied to Saudi Arabia
- Coordinate and review artwork briefs, annotations and checks, and approve final artwork in the artwork system
- Develop and execute submission strategies for new registrations, variations, renewals and labelling updates
- Maintain robust regulatory documentation and records in relevant regulatory systems and vaults
- Act as QMS champion for pack management and artwork control, ensuring training and compliance
- Facilitate regulatory risk register activities and collaborate with internal stakeholders and external authorities
Requirements
- Saudi National
- Bachelor's degree in pharmacy
- Valid SCFHS license as a certified pharmacist in Saudi Arabia
- Minimum 5 years experience in the pharmaceutical industry
- At least 3 years in Regulatory Affairs
- Strong knowledge of SFDA regulations and regulatory systems
- Bilingual (Arabic and English) with strong written and verbal communication skills
Full Job Posting
Role Summary
- The RA & Artwork Manager is responsible for leading pack management and artwork control for medicines and vaccines supplied to the Saudi market, 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.
Key Responsibilities
- 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.
Basic Qualifications
- 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.
Preferred Qualifications
- 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.
Why GSK?
- GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
- We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
- We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.
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