Site Name: Prague Posted Date: Jun 11 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK We are currently searching for a suitable candidate for the position of Regulatory Expert in the Czech Republic . In this role you will: Job Purpose: Ensure appropriate product approvals and maintenance for company product portfolio including labelling updates. Implement suitable regulatory policies and procedures to assist in achieving registration/commercialization of new company products (including licensed products) within the Czech Republic. Cooperation with Global Regulatory Teams. Coordinate translation of regulatory related labelling (SmPC, PIL, packaging) with keeping tough deadline for procedures (CP, MRP, DCP, NP). Coordinate artwork creation process within portfolio responsibility, cooperation with Artwork coordinators and Manufacturing sites Close cooperation with Medical department, QA, PV and Supply Cooperation with Therapeutical Area managers and Corporate Affairs Responsibility for EU and local legislation monitoring. Cooperation with Health Authorities (SÚKL, MoH) Why You? We are looking for professionals with these required skills to achieve our goals: Education Requirements (minimum expected) Technical, scientific and/or medical university degree Job Related Experience (minimum requirements) Experience in Regulatory Affairs Excellent written and verbal communication skills in Czech Very good written and verbal communication skills in English Other Job-Related Skills The ability to independently organize work and prioritize. The joy of teamwork and learning new things. Broader experience working with MS Office applications. Experience working in RA Databases and EU legislation knowledge GSK won the Randstad Award 2024 as the most attractive employer in the Czech Republic – British Chamber Of Commerce Czech Republic Closing Date for Applications – 30th June 2024 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. 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. 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