Regulatory Affairs Associate (1 year fixed-term contract)

We are currently looking for a Regulatory Affairs Associate to join and assist the BeNeLux local Regulatory Affairs team win both Belgium and the Netherlands and to manage the local activities from a regulatory perspective on a global cross-functional project.

• You manage preparation of new regulatory documents, dossiers and applications 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

• You analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs

• You actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance

• You build relationships with key stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK Consumer Healthcare policies and strategies

• You manage compliance within defined portfolio/activity streams in line with GSK Consumer Healthcare expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements, artworks as well as local MoH regulations)

• You work together with other functions (eg, marketing, supply chain) to deliver NPD and value engineering projects

• You support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated

• You proactively manage impact of regulatory changes within defined scope of responsibility on the business

• You maintain required regulatory compliance databases, systems and processes

• You maintain high level of knowledge on the science of products within defined portfolio

• You guarantee medical device registration to the National Health Authority databases.

• You guarantee cosmetic registration in the CPNP database in case of locally managed Cosmetics.

• Master in Pharmaceutical Sciences or Bachelor with relevant experience

• A first experience in the pharmaceutical industry, preferably in a regulatory function.

• Analytical mind, good attention to detail and problem solving skills within a structured process

• Good team player – works well in cross-functional teams

• Good time management skills, with ability to multi-task and work under pressure

• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods

• Ability to self-motivate and be resilient and focused under pressure

• Strong general computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook

• Fluent in French or Dutch and able to work effectively in English

• Li-GSK

Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. Diversity, Equity and Inclusion In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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