Senior Regulatory Specialist, Artwork Coordination

Senior Regulatory Specialist, Artwork Coordination

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

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

Accountable for development of packaging for new product and line

Effectively articulates Health Authorities (HA) and GSK requirements for labelling documents to GSK functions, and champions change as needed

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

Providing 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 packs

Supporting Labelling processes and systems in accordance with GSK policies and procedures

Provides additional support to GSK Labelling teams in the generation and maintenance of global and regional / country PI

Minimum 5 years of relevant experience (in pharmaceutical industry or regulatory)

English language skills as well as excellent written and verbal communication skills

High Attention to detail and excellent organization and time management skills, as well as a commitment to quality

Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes

Relevant experience or knowledge of packaging artwork management, regulatory affairs or manufacturing

Regulatory 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 guidance

Team working and problem solving skills

Operates with minimal supervision, making management aware of issues with high business impact and ability to think flexibly to meet shifting priorities and timelines

Awareness and application of relevant pharmaceutical regulation and new guidelines / policies relevant to product information

We also offer a wide range of additional benefits :

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)

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 (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 events

Modern office with creative rooms, fresh fruits every day

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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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