Regulatory Conformance Officer (12-month Fixed Term Contract (FTC) / Secondment) in Eggleston

Are you passionate about ensuring the highest standards of regulatory compliance within the pharmaceutical industry? As a Regulatory Conformance Specialist, you will play a crucial role in ensuring our products meet all licensing requirements and company standards. You will maintain the approval status of product licenses for both new and established products, uphold the manufacturer’s licenses for our Barnard Castle facility, and support regulatory information and site transfers and variations to existing products within agreed customer deadlines.

Key Responsibilities

• 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 and 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, elevate issues to ensure compliance, review Quality and Regulatory Intelligence, communicate impacts to the site, report regulatory intelligence to Central Regulatory, and review Pharmacopeia changes for specification impact.
• Maintain compliance with global market authorisations, support regulatory submissions, and ensure site operations remain aligned with changing regulatory requirements.
• Work closely with manufacturing and aseptic operations, contributing to the delivery of regulatory strategies, inspection readiness, and change implementation, ensuring that processes, specifications, and controls remain compliant and robust.

Qualifications

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

Fixed‑Term Contract (FTC) / secondment expected to last approximately 12 months.

Benefits

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

Equal Opportunity Employment

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.