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We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

Regulatory Conformance Officer (20-months Position)

The Barnard Castle site is located in the North East of England within the County Durham countryside. Barnard Castle is a critical secondary site for GSK with a large number of New Products coming through development from R&D. We manufacture and supply a huge range of different pharmaceutical products from Sterile Biological and Small Molecule Products to Liquid Inhalations and Dermatologicals. We have recently opened a new state-of-the-art aseptic digital facility focussed on producing GSKs pipeline of new biopharmaceuticals.

The site Regulatory Conformance activities are highly varied – from registration of New Chemical and Biological Entities, to routine license renewals and variations for mature products. The site commercially supplies approximately 120 markets and compliance with local requirements is key part of the Regulatory Compliance teams role.

Regulatory Conformance Officers provide expertise to ensure that products released from the Barnard Castle site are in compliance with licencing requirements and company standards. They establish and maintain the approval status of product licences for both new and established products manufactured at site and maintain the sites manufacturers licences. This includes provision of regulatory information to support business objectives, site transfers and variations to existing products within agreed customer deadlines.

This is a fantastic opportunity for someone seeking development in Regulatory or for people wanting to improve their business breadth and understand how all areas of a complex site operate and adhere to regulatory standards.

This is a site-based role based at Barnard Castle

In this role you will…

Be expected to establish and retain regulatory licences to supply and provide regulatory expertise for the site and on behalf of site for the range of products manufactured at Barnard Castle.

This is achieved through the following responsibilities:

• Liaising with multiple functions across site and within the global network establishing key partnerships with Operational Quality, New Product Introduction, Analytical Laboratories, Validation and Logistics on site, and with R&D, Global Regulatory Affairs and Local Operating Companies from within the global network.
• Supporting the commercialisation of new products from R&D, through development, clinical trial and commercial submission. Key focus is on coordinating submission authoring, reviewing and approval for the site working with the SMEs from the site project team to provide accurate and compliant information to support the regulatory filing.
• Representing Regulatory Conformance in project teams for new business and change projects as well as transfers and network strategy.
• Responding to questions from external regulatory authorities raised during technical review of submissions, variations and renewals. coordinating and preparing site responses, leading to approval of regulatory dossiers and ability of site to supply product. In addition, managing the delivery of data/information to fulfil post approval commitments made by the site.
• Reviewing site requests for change, assessing the potential for regulatory impact. Providing accurate advice to the change owner/initiator with respect to the change impact, raising RADARs to seek formal regulatory advice from central regulatory groups as appropriate. Where a regulatory impacting change is progressed the Regulatory Conformance Officer supports the Regulatory Implementation Strategy and communicates the approval status of the change to site using regulatory systems.
• Assessing regulatory changes received for impact on site, escalating issues to ensure continued compliance. Reviewing Quality and Regulatory Intelligence and communicating to site to determine impact. Reporting regulatory intelligence identified by site to Central Regulatory. Reviewing Pharmacopoeia changes to assess impact to specifications.
• Reviewing/approving site documentation for regulatory conformance e.g. manufacturing guides, laboratory methods and material specifications.
• Generating and maintaining Finished Drug Product Quality Specifications to ensure Barnard Castle products are tested and released in accordance with the registered requirements and local regulatory standards for the markets they are supplied.
• Responding to regulatory related enquiries from the stakeholders/customers in a timely manner, this includes medical information, deviation support and general enquiries. Providing accurate regulatory advice.
• Help maintain the end to end supply chain through supporting the site Pack Change process.
• Responsible for own training development as well as supporting others within the team.
• Drive continuous improvement initiatives within Regulatory Conformance to completion and provide support to other areas improvement projects.

Closing Date for Applications: 17th April 2023

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

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Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Degree in a science or related discipline. (Microbiology, Pharmacy, Chemistry or another related science)
• Knowledge of Pharmaceutical and Consumer Registration processes, Pharmacopeial standards, GMP, company systems and Regulatory expectations.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• A broad-based technical knowledge of most aspects of manufacturing, quality and regulatory activities/ requirements is essential for the role.
• Knowledge of change control processes, registration and regulatory procedures is desirable with an understanding of Quality and GxP applicable to the pharmaceutical and consumer industry is required.

Why GSK?

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 impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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