Regulatory Specialist, Artwork Coordination

Regulatory Specialist, Artwork Coordination

This role 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 will provide YOU the opportunity to lead key activities to progress YOUR career. 

These responsibilities include some of the following:

• Timely 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 teams
• Interface 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 sharing
• Operates with minimal supervision, making management aware of issues with high business impact
• Efficient management and communication of other Labelling documentation as required
• Providing support to GSK Labelling teams to help ensure quality and consistency of labelling documentation content and storage
• Supporting Labelling processes and systems in accordance with GSK policies and procedures
• Ensures accurate version control of documents for multiple labelling submissions and components
• Understands publishing and HA requirements for submission of packaging components and provides labelling components for HA submissions for centrally managed packs
• Participation in other projects and activities, such as contributing to the implementation of changes to processes within Labelling
• Support other labelling functions as needed (such as, Country Labelling, Global Labelling Committee work, audits). Actively builds an organizational network
• May have data review responsibilities for peers and may identify improvement opportunities for Labelling processes, policies and systems

Why You?

Qualifications:

• Bachelor’s degree in life sciences field or related field that is appropriate to the function. (Life sciences, pharmacy, commodity science or other related science or technical bachelor’s degree)
• Relevant experience (in pharmaceutical industry, life sciences or regulatory operations or labelling)
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner with the ability to interact with various functions
• High Attention to detail and excellent organization and time management skills, as well as a commitment to quality
• Ability to think flexibly to meet shifting priorities and timelines.
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

• English Language Skills

• Regulatory pack management experience (EU, International and/or US).
• Working knowledge of product information/labelling documentation and application to packaging
• Experience of supporting products registered via a variety of procedures, in particular, familiarity with associated packaging guidance
• Experience and familiarity of working within documentation databases and MS team sites
• Operates with minimal supervision, making management aware of issues with high business impact
• Ability to work carefully under time constraints and prioritize accordingly within a matrix team environment

Why Gsk?

• Career at one of the leading global healthcare companies

• Contract Of Employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Hybrid working model (where GSK site are in Poland)
• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, short Fridays option, health & well-being activities)
• Life insurance and pension plan
• Private 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 (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

Inclusion At Gsk:

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

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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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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