Regulatory Affairs & Pack & Artwork Manager📣 إعلان

Role Overview

GSK is seeking a Regulatory Affairs & Pack & Artwork Manager to join our team in Riyadh, Saudi Arabia. This full-time position requires 5-10 years of professional experience and is responsible for leading pack management and artwork control for medicines and vaccines supplied to the Saudi market. The role also encompasses key Regulatory Affairs activities across submissions, product lifecycle management, and labelling, acting as a central link between Regulatory Affairs, Supply, Quality, Marketing, and Medical functions.

Regulatory Affairs Management

The manager will oversee critical regulatory affairs functions, ensuring compliant, right-first-time regulatory outputs in line with SFDA guidelines and GSK global standards. Key responsibilities include:

• Developing and executing submission strategies for new registrations, variations, renewals, and labelling updates.
• Securing timely approvals in line with SFDA guidelines and GSK Standard Operating Procedures (SOPs).
• Maintaining robust regulatory documentation and records, including registration dossiers, variations, renewals, and labelling files, in relevant regulatory systems and vaults.

Pack and Artwork Oversight

This role involves comprehensive management of packaging and artwork to ensure accuracy and regulatory adherence for products supplied to Saudi Arabia:

• Owning end-to-end pack management and artwork control for medicines and vaccines.
• Ensuring labelling and artwork content comply with approved product information and local regulatory requirements.
• Coordinating and reviewing artwork briefs, annotations, and checks.
• Approving final artwork in the artwork system against source documentation, ensuring all impacted components are accurately updated.

Compliance and Risk Management

The manager will drive compliance and proactive risk mitigation across relevant processes, acting as a QMS champion:

• Ensuring training and compliance with global and local SOPs for pack management and artwork control.
• Facilitating the effective closure of audit and inspection actions.
• Managing regulatory risk register activities, including quarterly reviews, risk identification, and mitigation tracking.
• Collaborating with internal stakeholders and external authorities to resolve issues and drive continuous improvement.

Qualifications and Experience

Candidates should meet the following criteria:

• Experience: 5-10 years of professional experience in a relevant field.
• Basic Qualification: A valid SCFHS license as a certified pharmacist in Saudi Arabia.
• Preferred Qualification: Demonstrated ability to lead hybrid responsibilities across both regulatory and artwork functions.

Location and Work Type

This is a full-time position based in Riyadh, Saudi Arabia. The role offers an opportunity to contribute to a critical function within a global pharmaceutical company, ensuring product compliance and quality in the Saudi market.