Regulatory Affairs & Pack & Artwork Manager
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Key skills for this role
About the Role
GSK Saudi Arabia is seeking a Regulatory Affairs & Artwork Manager to lead pack management and artwork control for medicines and vaccines, while owning key regulatory activities.
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
- Develop and execute submission strategies for new registrations, variations, renewals, and labelling updates
- Maintain robust regulatory documentation and records in relevant systems
- Act as QMS champion for pack management and artwork control
- Facilitate regulatory risk register activities and collaborate with stakeholders
Requirements
- Saudi National
- Bachelor's degree in Pharmacy
- Valid SCFHS license as a certified pharmacist in Saudi Arabia
- Minimum 5 years' experience in pharmaceutical industry, including 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.
- This hybrid role acts as a central link between Regulatory Affairs, Supply, Quality, Marketing and Medical.
Key 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.
- 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.
- Facilitate regulatory risk register activities and collaborate with internal stakeholders and external authorities.
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.
- 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 and regulatory documentation platforms.
- Strong time management, organization and stakeholder management skills.
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