Fiona Leeper Email & Phone Number

United Kingdom

Inverness, Scotland, United Kingdom

Edinburgh, United Kingdom

Manchester, England

Edinburgh, United Kingdom

Inverness, Uk

Providing regulatory guidance on cross functional new product development project teams in the design and development of innovative blood glucose products. Regulatory support is provided by developing regulatory strategies to support global product launches as well as providing testing requirements to meet global regulatory submissions. Once the product has been developed and tested the role involves preparing and submitting 510(k)s, CE Technical Files and in-country registrations as and where required. The role also involves working with external agencies to progress product submissions to approval as well as obtaining advice on product Classifications and submission requirements. Review and approval of product claims and labelling, as well assessment of design changes pre and post submission are undertaken as part of the role.

Peterlee

SSL manufactured OTC pharmaceuticals, Medical Devices and Cosmetics, .This role was attached to a manufacturing site and provided regulatory support for manufacturing changes, conformance to registered details and the progression of any changes with regulatory authorities. Responsibilities included the compilation and submission of Product License Variations (PLVs) for both UK MHRA and EIRE IRB marketing authorisations and interaction with the regulatory agencies as and when required. The role also involved conformance activity by ensuring site documentation ranging from incoming material specifications to release Certificate of Analysis were in compliance with registered details, as well as answering any regulatory queries that manufacturing, marketing and R&D personnel may have had.

The role involved the project management of the regulatory activities required to implement manufacturing and supply chain rationalisation whilst ensuring compliance with global regulatory guidelines and requirements. Responsibilities included compiling Manufacturing Authorisation Applications and associated variations to be submitted to European and International regulatory authorities and making sure that these are produced and submitted to tight project time scales by liaising with GSK manufacturing sites and projects leaders to ensure that time scales were adhered to. Interfacing with colleagues within other company functions to aid compliance issues and find solutions.

Barnard Castle

The role provided input into regulatory and compliance issues for the manufacture of new and established drug products, liasing as appropriate within the company or suppliers. The role supported compliance by the interpretation of internal company standards; pharmacopoeia requirements and commitments made to regulatory authorities for licence applications. Responsibilities included established GSK Liquid and Topical products and any general regulatory queries that may arise. Responsibility was also for the progression of any regulatory activities that may have arisen from changes to the manufacturing or supply network and progressing these changes to approval to allow implementation of them. The role gave an overall picture of the full manufacturing process involved to produce a modern pharmaceutical drug product ranging from receipt of the raw material, manufacture and finally to release of the finished product.