Regulatory Affairs Associate
Position/Employment Type: Full-Time Temporary position, 1 year
This position has responsibility for a defined portfolio of products and other various activity streams within Regulatory Affairs in GSK Consumer Healthcare (CH), Denmark.
• Getting quality products to the Danish (Nordic) 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 Denmark in relation to obtaining and maintaining marketing authorizations
• 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.
• 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, in order to present GSK CH policies and strategies
• Manage compliance within defined portfolio/activity streams in line with GSK CH expections - support key processes and ways of working (e.g. in relation to GSK CMC, quality, product labeling requirements 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
This position has the responsibility for ensuring the planning, review and implementation of approved changes into artwork within Regulatory Affairs in GSK Pharma, Denmark.
• Develop and follow up on timelines and activities leading to uploaded packaging materials
• In cooperation with local Quality department, ensure implementation of changes in the packaging material are in accordance with relevant timelines, set by the Danish Medicines Agency and GSK guidelines
- University degree, preferably in life sciences/pharmaceutical-related science (e.g. Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
- Analytical mind, good attention to detail and problem-solving skills
- Good team player, works well in cross-functional teams
- Good time management skills, with ability to multi-task and work under pressure
- Ability to self-motivate and be resilient and focused under pressure
- Experience in Regulatory Affairs is preferred, but not a must
If you have any question about the recruitment, please contact Sylwia.firstname.lastname@example.org.
GSK's mission is to help patients to Do More, Feel Better and Live Longer. The GSK Consumer Healthcare business is a market leader in more than 30 countries and the number one company worldwide for over-the-counter medicines with strong brands such as Panodil, Sensodyne, Nicotinell and Voltaren. The GSK Pharma business is a world leader within vaccines, medicines to treat asthma, COPD and HIV medicines.
In addition to investing in research of new drugs, GSK takes on a special responsibility in providing vital medicines at production cost to the world's poorest countries. We work against strict ethical guidelines and lead the industry on transparency. Headquartered in London, GSK is one of the world's leading pharmaceutical and healthcare companies with approx. 110,000 employees globally. In Denmark (Copenhagen/Brøndbyøster) we employ 130 people within GSK Consumer Healthcare and GSK Pharma. Meet us at https://www.gsk.com/.
You may apply for this position online by selecting the Apply now button.
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