Site Name: Warsaw, Poznan Grunwaldzka

　　Posted Date: Nov 2 2023

　　This role is responsible for defining strategy and ensures delivery of Global/Regional/Country artwork throughout product lifecycle including launch into markets. This role manages day to-day interactions with vendor(s) to ensure delivery of quality Global/Regional/Country artwork to timelines, including provision of regulatory pack management advice.

　　This role executes agreed Global/Regional/Country artwork strategy and manages multiple project assignments simultaneously as well as identifies risks associated with Labelling and packaging components.

　　This role function as a senior specialist in selected labelling artwork coordination processes, leads the projects and provides support to staff.

　　Senior Regulatory Specialist, Artwork CoordinationTimely management and communication of documentation to support global and country/regional Artwork development and maintenance. Leveraging regulatory and packaging knowledge/experience to respond to content queries, working closely with Labelling content Leads, Supply Chain Managers and Artwork teamsInterface with the outsourced vendor as well as other Regulatory or GSK functions to support the delivery of market artwork, ensure consistency of processes and practices, include driving continuous improvement and best practice sharingAccountable for development of packaging for new product and lineEffectively articulates Health Authorities (HA) and GSK requirements for labelling documents to GSK functions, and champions change as neededEnsures accurate version control of documents for multiple labelling submissions and componentsUnderstands publishing and HA requirements for submission of packaging components and provides labelling components for HA submissions for centrally managed packsProviding support to GSK Labelling teams to help ensure quality and consistency of labelling documentation content and storage.Delivering input to responses to regulatory questions related to centrally managed packs and shared packsSupporting Labelling processes and systems in accordance with GSK policies and proceduresProvides additional support to GSK Labelling teams in the generation and maintenance of global and regional/country PI Why you?

　　Qualifications:Minimum 5 years of relevant experience (in pharmaceutical industry or regulatory)English language skills as well as excellent written and verbal communication skillsHigh Attention to detail and excellent organization and time management skills, as well as a commitment to qualityBroad understanding of the pharmaceutical industry, drug development environment, and regulatory processesRelevant experience or knowledge of packaging artwork management, regulatory affairs or manufacturingRegulatory pack management experience (EU, International and/or US)Working knowledge of product information/labelling documentation and application to packaging and experience of supporting products registered via a variety of procedures, in particular, familiarity with associated packaging guidanceTeam working and problem solving skillsOperates with minimal supervision, making management aware of issues with high business impact and ability to think flexibly to meet shifting priorities and timelinesAwareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information Why GSK?

　　We also offer a wide range of additional benefits:Career at one of the leading global healthcare companiesContract of employmentAttractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)Life insurance and pension planPrivate medical package with additional preventive healthcare services for employees and their eligible.Sports cards (Multisport)Possibilities of development within the role and company's structure.Personalized learning approach (mentoring, online training' platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)Supportive community and integration eventsModern office with creative rooms, fresh fruits every day Inclusion & Diversity at GSK:

　　Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.

　　GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.

　　We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ( [email protected] ) to further discuss this today.

　　We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. *Local restrictions/legal requirements

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　　Why Us?

　　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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

　　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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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　　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.

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