Regulatory Affairs Associate
12 month fixed-term contract
This position has responsibility for a defined portfolio of products and other various activity streams within Regulatory Affairs in GSK Consumer Healthcare (CH), Nordics. The role is based in Sweden, Stockholm or Denmark, Vallensbaek.
The purpose of the Regulatory department is:Getting quality products to the Nordic markets with optimal claims and keeping them there, by knowing relevant legislation and ensuring compliance. The department is responsible for contact with the Health Authorities in the Nordic markets in relation to obtaining and maintaining marketing authorisations (mainly national licenses and MRP/DCPs).Providing product-related information to other departments, authorities, consumers, health care professionals and trade associations.Providing pharmaceutical scientific guidance to marketing and sales departments.Responsible for driving and keeping artwork up to date to reach implementation datesKey business partner to the commercial business
In this role you will…Lead 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 marketAnalyse regulatory issues and communicate with key stakeholders. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needsActively contribute to the activity of a high performing team, including looking for ways to improve the performanceBuild relationships with key stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK CH policies and strategies and negotiate outcomesManage Regulatory compliance within defined portfolio/activity streams in line with GSK CH expectations – support key processes and ways of working (e.g. in relation to GSK CMC, quality, product labelling requirements, artworks as well as local authority regulations)Work together with other functions (e.g. marketing, supply chain) to deliver on new product development projects and product lifecycle projectsSupport the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicatedProactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the businessMaintain required regulatory compliance databases, systems and processesMaintain high level of knowledge on the science of products within defined portfolio
Qualifications & Skills:University degree in life science/pharmaceutical-related science (e.g. Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) or equivalentMinimum 1-3 years’ experience in regulatory positionAnalytical mind, good attention to detail and problem-solving skills within a structured processGood team player – works well in cross-functional teamsInterest in the commercial side of the business to ensure the Regulatory team is a key business partnerGood time management skills, with ability to multi-task and work under pressureWorks with a spirit of continuous improvement and innovation, creatively open to new ideas and methodsAbility to self-motivate and be resilient and focused under pressureAble to work effectively in EnglishFluent/Native in Swedish or Danish
Preferred Qualifications & Skills:Masters degree in relevant subject
Why Consumer Healthcare?
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.
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