Regulatory Conformance Officer
Location Barnard Castle
Salary up to £15.71 p/h
CY Partners have a fantastic opportunity with a global pharmaceutical organisation, who are looking for a Regulatory Conformance Officer to join their team in the quality department. The role is aligned with their site in County Durham however, offers flexible home based working. Initially available on a 6 month contract basis with good opportunity for extension to work on other projects past this point.
As Regulatory Conformance Officer, you will provide Regulatory Conformance expertise to ensure that products released from one of the main pharmaceutical manufacturing sites, are in compliance with licensing requirements and company standards. You will establish and maintain the approval status of product licenses for both new and established products manufactured at site and maintain the manufacturers licences for site. You will also be responsible for offering regulatory information to support business objectives, site transfers and variations to existing products within agreed customer deadlines.
Other responsibilities will include:
- 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 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.
For a confidential chat about the role and to apply, contact Helen Tomlinson at CY Partners on 07851246847 or send across your CV to Helen at [email protected]