Regulatory Conformance Specialist - 12m FTC with Benefits

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. 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.

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.

This role supports the delivery of critical regulatory projects across the product lifecycle. Key responsibilities include maintaining compliance with global market authorisations, supporting regulatory submissions, and ensuring site operations remain aligned with changing regulatory requirements.

Working closely with manufacturing and aseptic operations, the role contributes to the delivery of regulatory strategies, inspection readiness, and change implementation, ensuring that processes, specifications, and controls remain compliant and robust.

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 fulfil 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.

Please Note: This Fixed Term Contract (FTC) / secondment is expected to last circa 12 months in duration. Please ensure you have spoken with your line-manager to ensure they are supportive of your application (this includes a timely-release from your current responsibilities should you be offered the Secondment).

Basic Qualifications & Skills:

• 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:

• Degree in a scientific or related discipline (e.g., Microbiology, Pharmacy, Chemistry, or another related science).

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.

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.

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.