Regulatory Affairs & Quality Associate / Coordinator
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
• Maintain product licenses in compliance with local regulations.
• Registration plans for new products, major changes and life cycle management.
• Communicate with the distributors in each of the markets to ensure optimized and compliant Registration procedures.
• Collaborate with Medical, Marketing and Supply Chain and pro-actively ensuring Regulatory input is provided
• Implement strategies to improve (or maintain) the legislative, regulatory and recommendation environment to better achieve business goals of GSK
• Establish good relationships with distributers and local authorities.
• Ensures Regulatory compliance of Product Artwork and all promotional materials addressed to his/her market to local legislation and code
• Ensure that the business is aware of possible legislation changes that could impact GSK and advise higher management on appropriate course of action.
• Be part of the claim validation team of the GSK in his/her region of responsibility and sign off all consumer claims.
• Effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations/codes and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders.
• Provide regulatory intelligence knowledge to support the development and implementation of regulatory and business.
• Ensure proper archiving for all related document.
• Report any risks to their line managers.
Minimum 4 years experience in regulatory preferred in consumer or FMCG industry
Preferred experience in UAE
Valid UAE MOH License is an added value
Any additional related qualification will be a plus
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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