Jacqueline Lambert Email and Phone Number

Regulatory CMC and Compliance Professional

Sole responsibility for completion of a regulatory compliance project on behalf of the company’s customers through comparison of site and regulatory documentation. This includes:• Project management• Identification of non-compliances• Negotiation with the clients and site management• Proposal of regulatory strategies for closure of agreed non-compliances• Monitoring of approvals and implementation at site level as required

To ensure compliance with the Human Tissue Act (HTA) regulations, supporting staff to discharge responsibilities, providing expert advice and support within the university. Responsible for the Quality Management System with respect to HTA, conducting periodic internal audits to assess compliance with the Human Tissue Act and other relevant legislation, supporting research tissue banks and raising awareness of HTA within the university.

To ensure reliability of service across the Data Coordination team to ensure the smooth running of the department by providing an effective and efficient service.Principal accountabilities are departmental training, leadership and support to the department and initiatives; leading by example, applying leadership skills in the development of staff, with the ability to have effective collaboration with various functions within the UK business; performing user database administration, providing resourcing projections to local and corporate management.

To manage the regulatory team; provide regulatory expertise and services for the site, corporate functions and the company affiliates; maintain the site's Manufacturer's/Importers Authorisation and Product Marketing Authorisations; ensure compliance with current regulatory requirements, corporate directives and business priorities.

To ensure regulatory compliance of the site with current global Marketing Authorisations through an ongoing review and appraisal of site practices and documentation; advise on all regulatory aspects as required by the site in order to ensure that documents generated meet the standards required by the Regulatory Authorities; to prepare, submit and follow up Marketing Authorisation variations to the UK and ROI regulatory authorities, to Corporate Regulatory and to local Regulatory Departments; to co-ordinate supplier questionnaires in order to ensure that the site complies with CPMP guidelines such as the requirements for medicinal products to comply with controls on TSE and residual solvents.

To ensure regulatory compliance of the site with current global Marketing Authorisations through on-going review and appraisal of site practices and documentation; to prepare dossiers for Marketing Authorisation renewals in the current format; to prepare Marketing Authorisation variations for submission to the UK and ROI regulatory authorities, to Corporate Regulatory and to local Regulatory Departments; to provide the necessary regulatory support required to assist the transfer of manufacture of products both into and out of the Fawdon Manufacturing Centre.

To support the Quality Manager (QP) by carrying out the review of all documentation associated with the manufacture, packaging and analysis of production batches to ensure that only those batches which comply with cGMP and Marketing Authorisations are released to the customer; to liaise with the Operational Units in the event of deviations and to correct errors in documentation and to carry out training and education to ensure continuing compliance with cGMP.