GSK

pharmaceutical

RegulatoryConformanceOfficer

Barnard Castle, United Kingdom FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Regulatory Conformance Officer at GSK. Skills: regulatory conformance, regulatory compliance, product licensing. maintaining the approval status of product licenses for both new and established products. upholding the manufacturer's licenses for our Barnard Castle facility”

What You'll Achieve.

ensuring our products meet all licensing requirements and company standards; delivering excellence in regulatory conformance and compliance; delivery of critical regulatory projects across the product lifecycle; ensuring site operations remain aligned with changing regulatory requirements; ensuring that processes, specifications, and controls remain compliant and robust; ensuring alignment with regulatory requirements; ensure compliance

Industry & Context.

pharmaceutical
Eligibility Requirements

12-month Fixed Term Contract (FTC) / Secondment, fully site based

What They're Looking For.

Must Have

HND or ‘A’ levels in Scientific disciplines or equivalent experience, Background in analytical, laboratory, pharmaceutical industry, or regulatory roles, analytical approach with excellent attention to detail, Understanding of the regulated industry and its requirements, including Quality and GxP, Ability to interpret and apply registered details to ensure compliance in manufacturing and release processes

Nice to Have

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

What You'll Do.

maintaining the approval status of product licenses for both new and established products

upholding the manufacturer's licenses for our Barnard Castle facility

offering regulatory information and support for site transfers and variations to existing products within agreed customer deadlines

maintaining compliance with global market authorisations

supporting regulatory submissions

ensuring site operations remain aligned with changing regulatory requirements

delivery of regulatory strategies

change implementation

ensuring that processes

and controls remain compliant and robust

support the commercialization of new products from R&D through development

and commercial submissions

coordinating submission authoring

and approval for the site

providing accurate and compliant information to support regulatory filings

Represent Regulatory Conformance in project teams for new business

ensuring alignment with regulatory requirements

Coordinate and prepare responses to questions from external regulatory authorities during technical reviews of submissions

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

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

review Pharmacopoeia changes for specification impact

How You'll Work.

Team & Collaboration

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; Represent Regulatory Conformance in project teams for new business, change projects, transfers, and network strategy; Working closely with manufacturing and aseptic operations

Full Job Description

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 I

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