Regulatory Associate

Site Name: Espoo Posted Date: Jul 14 2022 Regulatory Affairs Associate Job purpose This position has responsibility for a defined portfolio of products and other various activity streams within Regulatory Affairs in GSK Consumer Healthcare (CH). The purpose of the department is: Getting quality products to the markets with optimal claims and keeping them there, by knowing relevant legislation and complying/respecting to it. The department is responsible for contact to the health authorities in relation to obtaining and maintaining marketing authorisations Providing product-related quality information to other departments, authorities, consumers, health care professionals and trade associations. Providing pharmaceutical scientific guidance to marketing and sales departments. In this role you will… 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 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 Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance Build relationships with key stakeholders and represent GSK in an appropriate manner according to company values, to present GSK CH policies and strategies Manage 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 labeling 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 projects Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated 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 Why you? Qualifications & Skills: Analytical mind, good attention to detail and problem-solving skills within a structured process Must be Native in Finnish and able to work effectively in English 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 Able to work effectively in English Ability to self-motivate and be resilient and focused under pressure Preferred Qualifications & Skills: Master’s 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. 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