Victoria Goff

Victoria Goff

Victoria graduated from university with a BSc in Chemistry with analytical science and began working as a quality control operative for ProSynth Ltd. In 2006 Victoria commenced a new role at Mundipharma Research Limited in the analytical team within Product Development. In this role Victoria gained extensive experience of drug development along with skills in project management and generation of regulatory documentation for clinical trials (Phase I-III) and Module 3. In 2017 Victoria moved to the Regulatory CMC team within Mundipharma Research to a role that involved authoring, review and submission of Module 3 MAA/NDA for Europe, APAC and LATAM and associated query response activities. Victoria also gained significant experience leading submissions for post approval changes in Europe, APAC and LATAM. In 2019 Victoria joined Kinapse as a Senior Manager in Regulatory CMC supporting multiple clients in both pre and post approval activities. Victoria rejoined Mundipharma in 2021 as the Head of Regulatory CMC and in this role and is responsible for the team providing regulatory CMC strategy across all the portfolios to maintain global compliance and support commercial opportunities.

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    Regulatory operations: Evolution and revolution


    ‘Operations’ does not quite do justice to the critical role that these individuals play in the global team

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    Updates to quality legislation from the EMA


    Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.

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    CMC acceleration is driven by a scientific revolution


    The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals

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    Regulating medicines in a surge of change


    Steve Hoare, Quality Regulatory Science and Safety Policy Director at The Association of the British Pharmaceutical Industry (ABPI),  discusses the impact of Brexit and COVID-19 on the pharmaceutical industry and how industry continue to evolve.

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    Selection and justification of regulatory starting materials


    A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.

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    Building best regulatory practices in Brazil


    Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.