Provide Regulatory Conformance expertise to ensure that products released from the Barnard Castle site are in compliance with licencing requirements and company standards.
Establish and maintain the approval status of product licences for both new and established products manufactured at site and maintain the manufacturers licences for Barnard Castle.
Offer regulatory information to support business objectives, site transfers and variations to existing products within agreed customer deadlines.
Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.
Responsibilities applicable to all roles at Barnard Castle PSC site:
· To work as a flexible and motivated member of the team.
· To follow all Standard Operating Procedures (SOPs) and/or Standards of Work (SW) applicable and in which the individual has been trained.
· To act at all times in compliance with Good Manufacturing Practices (GMP) and to report any quality issues.
· To act in a safe manner, always (in compliance with the Health & Safety at Work Act, and all other relevant legislation) and to use GSK safety reporting systems to highlight potential hazards.
· To remain up to date with all training requirements (both ‘classroom’ courses and computer based training through the ‘MyLearning’ internal platform).
· To take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes.
· To take part in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
Job Specific Responsibilities:
This is a key role within the Quality department, the Regulatory Conformance Officer is 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.
This is achieved through the following responsibilities:
· 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, and 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 trial and commercial submission. Key focus is on coordinating submission authoring, reviewing and approval for the site working the SMEs from the site project team to provide accurate and compliant information to support the regulatory filing.
· Representing Regulatory Conformance in project teams for new business and change projects as well as transfers and network strategy.
· Responding to questions from external regulatory authorities raised during technical review of submissions, variations and renewals, coordinating and preparing site responses, leading to approval of regulatory dossier and ability of site to supply product. In addition, managing the delivery of data/information to fulfil post approval commitments made by the site.
· Reviewing site requests for change, assessing the potential for regulatory impact. Providing accurate advice to the change owner/initiator with respect to the change impact, raising RADARs to seek formal regulatory advice from central regulatory groups as appropriate. Where a regulatory impacting change is progressed the Regulatory Conformance Officer manages the Regulatory Implementation Strategy and communicates the approval status of the change to site using regulatory systems e.g. OPAL and Suppliable Status.
· Assessing regulatory changes received for impact on site, escalating issues to ensure continued compliance. Reviewing Quality and Regulatory Intelligence and pharmacopoeia changes and communicating to site to determine impact. Reporting regulatory intelligence identified by site to Central Regulatory.
· Reviewing/approving site documentation for regulatory conformance e.g. manufacturing guides, laboratory methods and material specifications.
· Generating and maintaining Finished Drug Product Quality Specifications to ensure Barnard Castle products are tested and released in accordance with the registered requirements and local regulatory standards for the markets they are supplied.
· Responding to regulatory related enquiries from the stakeholders/customers in a timely manner, this includes medical information, deviation support and general enquiries. Providing accurate regulatory advice.
· Help maintain the end to end supply chain through supporting the site Pack Change process.
· Ensure all work complies with safety and quality regulations including GxP and Data Integrity requirements.
· Responsible for own training development as well as supporting others within the team.
· Drive continuous improvement initiatives within Regulatory Conformance to completion and provide support to other areas improvement projects.
Preferred Level of Education
Degree in a science or related discipline.
(Microbiology, Pharmacy, Chemistry or another related science)
Minimum Level of Job-Related Experience Required
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 with understanding of Quality and GxP applicable to pharmaceutical and consumer industry is required.
Knowledge of Pharmaceutical and Consumer Registration processes, Pharmacopoeial standards, GMP company systems and Regulatory expectations.