Regulatory and Access Community Connects

Louise Knowles

Deputy Director, Innovation Accelerator and Regulatory Science, MHRA

Louise has over 17 years of experience working in Scientific roles across the Civil Service, and joined the MHRA in October 2023. The Innovation Accelerator and Regulatory Science team provides innovators enhanced access to MHRA scientific expertise and regulatory guidance, bringing together the work of the Innovation Office, Horizon Scanning functions as well as leading on the delivery of the Innovative Licensing and Access Pathway (ILAP) and the Innovative Devices Access Pathway (IDAP).  She was previously the Head of Research Capacity and Growth at DHSC and part of the leadership team for the National Institute for Health and Care Research, providing the strategic leadership and oversight of the NIHR Translational Research Infrastructure and NIHR Clinical Research Network as well as leading work to deliver on the ambitions set out in the UK Vision for Clinical Research Delivery. Prior to her role in DHSC she was a Foresight Researcher at the Government Office for Science and led a number of Research Programmes for the Food Standards Agency.

Rosie Lindup

Policy and Public Affairs Manager, BioIndustry Association

Previously, Rosie worked as a Senior Research Consultant at a Westminster-based public affairs agency, where she supported clients from a range of sectors, including pharmaceuticals, technology and financial services. Prior to that, Rosie worked as a Management Consultant at KPMG, where she assisted on financial and regulatory projects with large corporate clients. She has a BA in Human, Social and Political Sciences from the University of Cambridge.

Roz Sutton

Senior Director, Regulatory Affairs, tranScrip Ltd

Roz has 25 years of regulatory experience in a variety of different companies including  Roche Pharma and GlaxoSmithKline as well as SME companies such as DLRC and Medeva Group- Research.  She has held positions of growing impact and responsibility over the years from regulatory professional to team leader and group director.

She brings extensive regulatory expertise, including FDA and EU Scientific Advice, Paediatric Investigation Plans, Orphan Drug strategy, MAA submissions, Clinical Trial Applications, Investigational New Drug Applications, FDA Model Informed Drug Development, Breakthrough Designation, PRIME applications and PRIME Rapporteur interactions, Due Diligence and Gap analysis.

Roz holds a BSc in Pharmacology and a Certificate of Training Practice, an accredited qualification from the Institute of Personnel. Over the course of her career, she has gained extensive experience in various leadership and regulatory roles within the pharmaceutical industry, particularly at Roche Pharma and DLRC Regulatory Consultancy, as well as in research with Medeva Group.

At Roche Pharma, Roz served as both a Team Leader and Regulatory Lead. In this capacity, she was responsible for driving global regulatory strategies, including assessing accelerated approval pathways, special designations, and developing pediatric strategies. She led health authority interactions and provided regulatory expertise for due diligence activities. In response to the COVID-19 pandemic, Roz embraced agile working approaches, ensuring the integrity and safety of ongoing studies. Additionally, she created a global early talent program aimed at developing future-ready regulatory affairs professionals and led a cross-functional team focused on reducing clinical trial costs by minimizing IMP wastage and utilizing generics and biosimilars in place of branded products.

As a Senior Program Manager at Roche, Roz continued to drive innovative global regulatory strategies and adopted agile working methods, including simplifying the IND process to facilitate FDA reviews. Her role involved EU partner and regulatory lead responsibilities in the neuroscience therapy area, where she developed global regulatory strategies for Alzheimer’s and Huntington’s diseases. She also pioneered discussions with the FDA as part of their model-informed drug development pilot, which led to a successful collaboration with the agency.

During her time at DLRC Regulatory Consultancy, Roz served as a Regulatory Team Leader, where she developed and implemented commercially focused global regulatory strategies, particularly within the Oncology Franchise. She also project-managed the preparation, review, and submission of regulatory documents, including MAA submissions, Scientific Advice, Paediatric Investigation Plans, Orphan drug applications, and clinical trial applications (INDs).

Earlier in her career at Medeva Group Research, Roz led product license variations for labeling and CMC changes, submitted clinical trial applications, and managed interactions with the MHRA, further enhancing her regulatory expertise.

Roz’s diverse experience has equipped her with a comprehensive skill set in global regulatory affairs, clinical trial management, and cross-functional leadership, making her well-prepared to navigate complex regulatory environments and contribute to the success of pharmaceutical development projects.