Regulatory Affairs & Pack & Artwork Manager

Role Overview

GSK Saudi Arabia is dedicated to advancing Vision 2030 and the Saudi National Agenda, with a strong commitment to local talent development and the empowerment of Saudi nationals through targeted hiring, training, and career growth initiatives. As a key contributor to this mission, the Regulatory Affairs & Pack & Artwork Manager plays a pivotal role in ensuring the seamless integration of regulatory compliance and high-quality packaging and artwork for medicines and vaccines distributed across the Saudi market. This hybrid position bridges critical functions within Regulatory Affairs, Supply Chain, Quality Assurance, Marketing, and Medical Affairs, driving excellence in regulatory submissions, product lifecycle management, and labelling in full alignment with Saudi Food & Drug Authority (SFDA) regulations and GSK’s global operational standards.

Key Responsibilities

The Regulatory Affairs & Pack & Artwork Manager is entrusted with the following core responsibilities to uphold GSK’s commitment to regulatory integrity and operational excellence:

• End-to-End Pack Management & Artwork Control: Oversee the complete lifecycle of packaging and artwork for pharmaceutical products, ensuring that all labelling and artwork components strictly adhere to approved product information and comply with local regulatory mandates set forth by the SFDA.
• Artwork Development & Approval: Lead the coordination, review, and approval of artwork briefs, annotations, and final artwork submissions within the designated artwork system. Validate that all impacted packaging components are accurately updated and aligned with source documentation to prevent discrepancies.
• Regulatory Submission Strategy & Execution: Develop and implement robust submission strategies for new product registrations, variations, renewals, and labelling updates. Champion right-first-time submissions to secure timely approvals in accordance with SFDA guidelines and GSK’s Standard Operating Procedures (SOPs).
• Documentation & Compliance Management: Maintain meticulous regulatory documentation and records, including registration dossiers, variations, renewals, labelling files, and artwork documentation, within GSK’s regulatory systems and secure vaults to ensure audit readiness and regulatory compliance.
• Quality Management System (QMS) Leadership: Serve as a QMS champion for pack management and artwork control, overseeing training initiatives, ensuring adherence to global and local SOPs, and driving the effective resolution of audit and inspection findings to mitigate risks and enhance compliance.
• Regulatory Risk Management: Facilitate comprehensive regulatory risk register activities, including quarterly reviews, risk identification, and mitigation tracking. Collaborate closely with internal stakeholders and external regulatory authorities to proactively address challenges, resolve issues, and foster a culture of continuous improvement across the organization.

Qualifications & Competencies

To excel in this dynamic role, candidates must meet the following qualifications and demonstrate the following competencies:

• Education & Licensing: Bachelor’s degree in Pharmacy from a recognized institution, complemented by a valid Saudi Commission for Health Specialties (SCFHS) license as a certified pharmacist in Saudi Arabia.
• Professional Experience: Minimum of 5 years of relevant experience in the pharmaceutical industry, with at least 3 years dedicated to Regulatory Affairs. Prior exposure to SFDA regulations, submission processes, variations, and renewals is essential.
• Language Proficiency: Fluency in both Arabic and English, with exceptional written and verbal communication skills to engage effectively with diverse stakeholders across the organization and regulatory bodies.
• Technical & Soft Skills: Demonstrated expertise in artwork and pack management processes, familiarity with artwork control tools (e.g., design and review software), and proficiency in regulatory documentation platforms or vaults. Strong time management, organizational agility, and stakeholder management capabilities are critical to balancing hybrid responsibilities across regulatory and artwork functions.

Diversity & Inclusion

GSK is an Equal Opportunity Employer, committed to fostering a workplace that values diversity and inclusion. All qualified applicants will receive equal consideration for employment without discrimination based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, or any other legally protected basis. By embracing diverse perspectives and backgrounds, GSK aims to drive innovation, enhance collaboration, and deliver meaningful impact to patients and communities worldwide.