Commercial Officer - United Kingdom - 73 Ltd

Description

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, 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 trials, and commercial submission. This means working with site project team SMEs to provide accurate and compliant information to support the regulatory filing.
Responding to questions from external Regulatory authorities. This means coordinating and preparing site responses, leading to approval of regulatory dossiers and ability to supply medicine. In addition, managing the delivery of data/information to fulfil post approval commitments made by the site.

Assessing site change controls for potential regulatory impact - providing accurate advice to the change owner with respect to the change impact, raising RADARs to seek formal Global Regulatory Affairs advice where required.

Generating and maintaining Finished Drug Product Quality Specifications (PQS) to ensure site products are tested and released to market in accordance with the registered requirements and local regulatory standards.

Responsible for own training development as well as supporting others within the team and drive continuous improvement initiatives within Regulatory Conformance to completion and provide support to other areas improvement projects.

Contract

We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

We prioritise innovation in vaccines and specialty medicines to prevent and treat disease.
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