• Manage preparation of new regulatory documents/dossiers to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
• Support lifecycle of existing portfolio, ensure Variations and Renewals are submitted/approved in timely manner
• Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance
• Manage compliance within defined portfolio in line with GSK CH expections - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations)
• Work together with other functions (eg, marketing, supply chain) to deliver New Product launches
• Proactively manage impact of regulatory changes within defined scope of responsibility on the business
• Maintain required regulatory compliance databases, systems and processes
• Maintain high level of knowledge on the science of products within defined portfolio
• Higher Education (Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
• A minimum of 1.5 years experience in Regulatory Affairs
• English: Intermediate
GlaxoSmithKline is one of the world’s leading over-the-counter healthcare companies. We hold number one positions in Wellness across 36 markets, and are market leaders in specialist oral care.
Our aim – to help as many people as possible do more, feel better, live longer.
Our history started 150 years ago. We are owners of the most popular brands in the world such as Sensodine®, Coldrex®, Voltaren®, Theraflu®, Parodontax®, Corega®, Otrivin®, Phisiogel® and so on.
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