Reg Publishing Submission Specialist, SDE - Publishing

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Position Summary

You will manage regulatory publishing and submissions to Health authority. You will work with cross-functional teams to prepare, assemble, and deliver submissions. We value attention to detail, clear communication, and a continuous improvement mindset. This role offers growth, real impact on global health work, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together

Responsibilities

Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures

Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format

Participate & Lead in the creation and implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality.

Deliver of complex submission packages independently, to agreed schedule and technical specification

Check compliance of others’ work with requirements and standards

Advise and assist authors with more complex or non-routine content preparation or document management procedures

Preferred Qualification

1-6 years of relevant experience of preparing electronic regulatory submissions .

Excellent computer knowledge (e.g. MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer etc) and preferably experience with the use of complex IT tools in a large organization.

Bachelors or Master’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment

Skills

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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