Site Name: Helsinki Porkkalankatu Posted Date: Feb 4 2025 Regulatory Specialist - 1-year temporary contract. Join our team as the Regulatory Specialist for a specified product portfolio! This exciting role encompasses the responsibility for both national and central licenses, as well as projects that are still in development. Be the regulatory responsible for your assigned product portfolio, offering your expertise in cross-functional settings to support and drive our business forward. If you are passionate about regulatory affairs and ready to make a significant impact, we want to hear from you! Key Responsibilities include, but are not limited to: Prepare and submit high-quality regulatory submissions in compliance with local and European requirements, ensuring timely delivery. Interact effectively with authorities and collaborate with Headquarters to respond to inquiries. Update local labelling (SmPC, PIL, pack-label, and compendium) in Finnish and Swedish language to ensure compliance with local regulations. Ensure pack artwork complies with legislation and GSK processes. Deliver high-quality local translations in Finnish and Swedish agreed with internal partners, according to SOP and timelines. Regularly update regulatory databases to maintain compliance. Keep fully aware of local and EU regulatory requirements and GSK Regulatory Processes and Policies Why you? Basic Qualifications & Skills:   BSc or MSc degree in Life Sciences, Pharmacy, or a related field. Relevant (1-3 years) experience in regulatory affairs and the pharmaceutical industry. Basic understanding of regulatory affairs and the pharmaceutical industry. Understanding of regulatory databases and the importance of maintaining compliance. Good understanding of IT systems and ability to learn and adapt to new processes in a timely manner. Ability to manage tasks independently Preferred Qualifications & Skills: Ability to assist in regularly updating regulatory databases to ensure accuracy and compliance. Strong organizational skills to ensure timely delivery of translations and regulatory documents. Able to influence and to liaise with internal and external stakeholders Closing Date for Applications – 21st February 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert.  When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. GSK has bold commercial ambitions for the future. By 2031, we aim to deliver £38 billion in annual sales – building from existing strong performance momentum which will significantly increase the positive impact we can have on the health of billions of patients around the world. Our Ahead Together strategy means intervening early to prevent and change the course of disease, helping to protect people and support healthcare systems. Our portfolio is made up of vaccines, specialty medicines and general medicines. These are the three different types of products we create to prevent and treat disease, many with the potential to be first-or best-in-class. If you are interested in joining us, find out more: Annual Report 2023 Product Pipeline Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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