Job Description

Site Name:

UK - County Durham - Barnard Castle

Posted Date:

May 7 2025

Are you passionate about ensuring the highest standards of regulatory compliance within the pharmaceutical industry? Do you have the expertise to maintain and enhance product licensing and regulatory conformance?


If so, we have an exciting fully site based Fixed term contract/secondment opportunity for you at our Barnard Castle site.

GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK's blockbuster products, the site contributes revenues of ~$2Bn annually.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.


We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.


Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK


As a Regulatory Conformance Specialist, you will play a crucial role in ensuring our products meet all licensing requirements and company standards. Your responsibilities will include maintaining the approval status of product licenses for both new and established products, as well as upholding the manufacturer's licenses for our Barnard Castle facility.


You will be a key contributor to our business objectives by offering regulatory information and support for site transfers and variations to existing products within agreed customer deadlines. Join us and be part of a team dedicated to delivering excellence in regulatory conformance and compliance.

In this role you will...

Collaborate with multiple functions across the site and the global network, establishing partnerships with Operational Quality, New Product Introduction, Analytical Laboratories, Validation, Logistics, R&D, Global Regulatory Affairs, and Local Operating Companies. Support the commercialization of new products from R&D through development, clinical trials, and commercial submissions, coordinating submission authoring, reviewing, and approval for the site, and providing accurate and compliant information to support regulatory filings. Represent Regulatory Conformance in project teams for new business, change projects, transfers, and network strategy, ensuring alignment with regulatory requirements. Coordinate and prepare responses to questions from external regulatory authorities during technical reviews of submissions, variations, and renewals, managing the delivery of data/information to fulfill post-approval commitments. Review site requests for change, assess regulatory impact, provide accurate advice to change owners/initiators, and support the Regulatory Implementation Strategy, communicating approval status to the site. Assess regulatory changes for site impact, escalate issues to ensure compliance, review Quality and Regulatory Intelligence, communicate impacts to the site, report regulatory intelligence to Central Regulatory, and review Pharmacopoeia changes for specification impact.

Why you?
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Basic Qualifications & Skills:

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

HND or 'A' levels in Scientific disciplines or equivalent experience. Background in analytical, laboratory, pharmaceutical industry, or regulatory roles. Strong analytical approach with excellent attention to detail. Understanding of the regulated industry and its requirements, including Quality and GxP. Broad-based technical knowledge of manufacturing, quality, and regulatory activities/requirements, with knowledge of change control processes, registration, and regulatory procedures being desirable. Ability to interpret and apply registered details to ensure compliance in manufacturing and release processes.

Preferred Qualifications & Skills:


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

Broad-based technical knowledge of manufacturing, quality, and regulatory activities/requirements, with knowledge of change control processes, registration, and regulatory procedures being desirable. Ability to interpret and apply registered details to ensure compliance in manufacturing and release processes. Degree in a scientific or related discipline (e.g., Microbiology, Pharmacy, Chemistry, or another related science).

Closing Date for Applications: 21st May 2025


Please take a copy of the , 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.

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.


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 Ukdiversity.recruitment@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.


Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .

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