Site Name: Mississauga Milverton Drive, Poznan Grunwaldzka, Warsaw Rzymowskiego 53 Posted Date: Mar 13 2025 Step into the role of Regulatory Project Manager, Artwork Coordination at GSK, where your expertise will shine in both local and global artwork coordination. You'll be the go-to person for stakeholders, leading with confidence and providing valuable training and mentorship to your team. Representing Global Labelling (GL) Artwork Coordination, you'll play a pivotal role in various projects, ensuring smooth communication and coordination. Join us and be part of a vibrant team dedicated to excellence in artwork coordination! This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Efficient management of creating and preparing updates to Artwork including impact assessments and ensuring compliance with associated timelines. Act as subject matter expert in multiple Global Labelling Artwork Coordination activities and/or US/EU carton/container labelling requirements. Support the LOCs in issue resolution relating to regulatory artwork requirements. Author responses to Regulatory Agency questions about carton and container labelling/artwork requirements. Effective planning of own and the job which is coming from matrix team, prioritization, communication, and delivery of quality labelling documents according to company timelines and submission requirements. Participation in other projects and activities, such as leading implementation of changes to artwork and labelling processes. Proactively identify areas for improvements/efficiencies in existing artwork coordination processes. Subject Matter Expert in Global and regional/country carton and container artwork content and process. Deep understanding and knowledge of biopharmaceutical Labelling. Knowledge of Vaccine-Pharma artwork requirements and processes. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Undergraduate Degree or equivalent practical experience.in Science or Life Science area preferred. 5 years relevant experience (in pharmaceutical industry or regulatory). Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory). Attention to detail, excellent organization and time management skills to handle multiple projects for different customers. Excellent written and verbal communication skills and ability to present information in a clear and concise manner. Ability to think flexibly in order to meet constantly shifting priorities and timelines and to independently provide solutions to issues. Excellent understanding of the pharmaceutical industry, and regulatory processes. Excellent understanding of carton and container labelling (e.g. significant experience in managing global/regional/local carton and container labelling artwork for submissions. Ability to build expertise for newer areas or significant changes/requirement (e.g. new regulatory requirements, working with partner companies). Set-up/lead process improvements for new regulatory requirements that have long-term impact on the delivery within the function and across functions. Experience in authoring and/or updating Labelling documents by identifying areas for efficiencies in existing Labelling processes. Acts as the Expert to be consulted across function for any projects. Training/mentoring other staff. Must be able to lead team to deliver consistently within a technically complex and highly regulated environment within a global organization. Must be able to coach and mentor others joining new in labelling team. Preferred Qualifications: If you have the following characteristics, it would be a plus: Bachelors / Master’s degree in Life Sciences or Pharmacology Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. LI-GSK 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. GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting. 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