Regulatory Conformance Officer

Job description

Site Name: UK - County Durham - Barnard Castle
Posted Date: Apr 23 2024

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

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 mature 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 site-based role based at Barnard Castle, UK.

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.

In this role you will...

• 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, 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 trials, and commercial submission. Key focus is on coordinating submission dossier authoring, reviewing and approval for the site. This means working with site project team SMEs to provide accurate and compliant information to support the regulatory filing.
• Responding to questions from external Regulatory authorities. This means coordinating and preparing site responses, leading to approval of regulatory dossiers and ability to supply medicine. In addition, managing the delivery of data/information to fulfil post approval commitments made by the site.
• Assessing site change controls for potential regulatory impact - providing accurate advice to the change owner with respect to the change impact, raising RADARs to seek formal Global Regulatory Affairs advice where required.
• Generating and maintaining Finished Drug Product Quality Specifications (PQS) to ensure site products are tested and released to market in accordance with the registered requirements and local regulatory standards.
• Responsible for own training development as well as supporting others within the team and drive continuous improvement initiatives within Regulatory Conformance to completion and provide support to other areas improvement projects.

Why you?

Basic Qualifications & Skills:

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 & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• 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.

Closing Date for Applications: 7th May 2024

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.

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.

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.

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