Regulatory Excellence: Delivered

Dr Lorraine Marsh (PhD) BSc PGCert FTOPRA

Associate Director, Regulatory Affairs

Dr Lorraine Marsh is a highly experienced consultant with more than 25 years’ experience in the pharmaceutical industry – in both brand leader and generics and in Human and Veterinary Medicines. She has a passion for learning and sharing her considerable knowledge and has a ‘right first time attitude’ with an incredible eye for detail. Her enthusiasm for her profession is catching and she is a positive and engaging person who enjoys a challenge!

Lorraine was awarded a PhD in pharmaceutics in collaboration with Reckitt Benckiser plc and the University of Portsmouth in 2001.

Clare Arnold

Executive Business Manager

Clare Arnold has been expertly supporting businesses for over 20 years. She is highly experienced and knowledgeable in a wide range of business arenas – from Office Management and Executive Assistant roles for senior company directors through to leading Social Media Campaigns.

Clare has a track record of strong performance and enthusiasm in supporting all levels of the business to develop and streamline systems, procedures and working practices to maximise the efficiency of individuals, teams and the business as a whole.

Rob Heathman BSc MTOPRA

Clinical Regulatory Affairs Consultant

Rob Heathman holds a First-Class honours degree in Chemistry and is a PRINCE2 Practitioner with nearly 25 years’ experience in industry. Rob is a Senior Regulatory Affairs Consultant who specialises in complex clinical trials across the UK, EU and global markets.

Prior to specialising in clinical trials, Rob managed government R&D commercialisation programmes for medicines and medical devices in the pre-clinical stages of development for a number of leading global healthcare providers.

Rob also provided board-level strategic advice and guidance to university spin-out companies focusing on a range of healthcare technologies. Rob brings a diverse range of pharma/biotech experience to the team and is always keen to apply this expertise to new challenges.

Natasha Long BSc

Associate Director, Regulatory Affairs

Natasha is a highly experienced Regulatory Affairs specialist with over 20 years’ experience across the pharmaceutical industry. Calm, focused and collaborative, she brings clear strategy and strong project leadership to complex regulatory challenges.

Prior to joining Fusion Pharma, Natasha held roles across big pharma, CROs, SMEs and consultancies.

Her expertise spans the full product lifecycle, including global regulatory strategy, dossier authoring, variations, scientific advice and regulatory intelligence.

She is also an experienced trainer and conference speaker, known for delivering clear, practical regulatory insight.

Dilyana Tosheva MSc BSc

Senior Regulatory Consultant

Dilyana is an experienced Regulatory Affairs professional specialising in UK and EU regulatory strategy for human medicines. Dilyana helps clients navigate complex and evolving requirements with clarity and confidence.

With experience working in both the MHRA and in industry, Dilyana brings a strong dual perspective across the full product lifecycle, including clinical trials, MAAs, variations, biologics and biotechnology medicinal products

She has a particular interest in rare diseases, immunology and endocrinology, and is passionate about supporting the development and approval of medicines that make a meaningful difference to patients.

Sophie Milden BSc MSc MNIMH

Regulatory Consultant

Sophie is a highly organised and detail-oriented Regulatory Affairs professional with over 14 years’ experience in the pharmaceutical industry. She has a strong background in OTC and pharmacy medicines, with particular expertise in CMC writing and Traditional Herbal Registrations.

Sophie began her career at a GMP manufacturing site before moving into Regulatory Affairs, giving her a solid foundation in quality and compliance. Her experience spans the full product lifecycle, including initial marketing authorisations, lifecycle management, variations, renewals, PSURs and labelling, alongside direct interactions with Health Authorities across the UK, EU and globally.

Aidan Roberts BSc

Regulatory Consultant

Aidan is a Regulatory Affairs professional with over seven years’ experience in the pharmaceutical industry. Detail-focused and solutions-driven, he combines regulatory expertise with a strong interest in systems, process improvement and technology.
 

Having begun his career in Quality Assurance, Aidan brings a practical, process-driven approach to regulatory work. His experience includes lifecycle management, UK and EU submissions, product information, SOP authoring and QMS management.

He is known for developing practical tools, improving processes, and delivering clear, engaging training.