Our Team

Dianne Lee, CEO and founder of DLRC, leads the organisation's strategic operations across the UK, EU, and US. Prior to DLRC’s inception in 2005, Dianne was an independent contractor for renowned pharmaceutical firms. She served as Director of Regulatory Affairs at Serono UK and contributed to Schering Plough and SK&F. Dianne's expertise is fortified by her qualifications in Applied Biology, a Diploma in Company Direction (Institute of Directors), and her TOPRA Fellowship. Committed to advancing global healthcare, she champions DLRC's unwavering dedication to regulatory excellence while fostering positive impacts on both people and the planet.

Cheryl joined DLRC in October 2022. Cheryl is a senior executive with extensive experience in a variety of sectors. Cheryl has many demonstrable achievements in business strategy and P&L optimisation in start-up, growth phase and major transformations. Throughout her extensive career, Cheryl has proven expertise in Finance, Procurement, IT, Supply Chain, Quality, Business Development, Corporate Governance & Alliance Management. Cheryl uses these varied skills to maximise business value.

Cheryl has a keen interest in the development of people and, to this end, has trained as an executive coach at the University of Strathclyde. Since stepping down from her executive role at the end of 2020, Cheryl has focused on assisting companies via non-executive roles that fit her interests and add value to society using innovative technologies in healthcare.

Cheryl is a fellow of the Association of Chartered Certified Accountants and holds an MBA from the University of Hertfordshire.

Wafa Bouaziz is the Managing Director of DLRC’s EU & US Affiliates. Wafa joined Orphix in April 2017 and has been leading the team in Germany since December 2018.

She is a global regulatory professional with broad experience across various therapeutic areas, including rheumatology, anti-infective, dermatology and oncology. She has strong scientific and regulatory expertise in driving both early development projects (CTA and IND submissions) and full development programs (MAA and NDA/BLA). She has led teams through complex global regulatory submissions and interactions with several global health authorities (including FDA, EMA and European national regulatory agencies).

Wafa has mainly worked on orphan drugs supporting regulatory procedures, including orphan drug designations, orphan maintenance, PIPs, scientific advice, MAA and BLA. Wafa is a pre-clinician with a PhD in Molecular and Cellular Biology from the University of Paris Diderot (France).

Claire’s role involves shaping the company's commercial strategy and leading the business development team. Claire has many years of Industry experience and a track record of success building teams that are laser-focused on delivering for clients and creating lasting value in partnerships. Having worked with GSK and AstraZeneca and global and niche CROs, she is well-placed to support DLRC's new clients in their journey to navigate the increasing complexities of the regulatory landscape successfully.

Claire obtained a bachelor’s in nursing and began her pharmaceutical career in clinical project management. She then studied for an MPhil in translational medicine & therapeutics at the University of Cambridge.

Alisdair has a wealth of experience in leading regulatory consulting teams and transforming regulatory services from his time with Parexel and the consulting division of KPMG.
He began his pharmaceutical career in 2001 as a medicinal chemist with GlaxoSmithKline. Subsequently, he has accumulated many years of experience across a broad range of regulatory affairs disciplines in a consulting environment. Additionally, he has been involved in designing and implementing a number of transformational regulatory programs in regulatory services. He has also obtained the TOPRA PG Cert in Regulatory Affairs. This combined experience enables him to understand the needs of our clients, allowing him to oversee and innovate DLRC’s Consulting services to meet these needs.

Alisdair has a Master’s degree in Chemistry from Imperial College, London.

Annette joined DLRC in 2016, taking on the responsibility of DLRC's Quality Management System (QMS). In addition, Annette has provided regulatory expertise for a diverse client base in EU clinical trial authorisations, scientific advice procedures, orphan designation procedures, PIPs and centralised MAA filings.

Prior to joining DLRC, Annette worked in pharma and consultancy with roles in regulatory affairs, pharmaceutical manufacturing and product technical information. Annette has a BSc in Science and is a member of the Royal Society of Biology and the Research Quality Association.

Since joining DLRC in 2022, Chris has been responsible for all finance-related activities within DLRC. This includes budgeting and forecasting, strategic planning, liquidity, and all accounting processes. Chris also owns Information Technology, systems strategy, and back-office operations.

Chris has over 25 years of experience in finance across different sectors, including healthcare outsourcing, consulting, supply chain and logistics, and pharmaceuticals.
Chris is a Fellow of the Chartered Institute of Management Accountants and holds a degree in Modern History from the University of London.

Kevin joined the company in 2009. In addition to overseeing business growth, Kevin has led regulatory teams in successfully delivering complex regulatory filings, including centralised MAAs, orphan applications, and scientific advice procedures.

Before joining DLRC, Kevin held positions of increasing responsibility within Global Regulatory Affairs at Roche. This included acting as the global regulatory lead for successful MAA/NDA filing projects and representing the global regulatory function on the non-clinical drug safety board.
Kevin has a BSc in Biochemistry, a post-graduate diploma in Regulatory Affairs from the University of Cardiff and is a Fellow of TOPRA.

James joined the company at the start of 2021 and during that time has focused on supporting clients in their readiness to work under the CTR. James supports organisations with training, procedural gap analysis, re-defining operating models and provides strategic support for CTA preparation and submission. In his Business Transformation role, James supports the company’s growth by driving and leading change, managing company communication, and streamlining processes to ensure optimal support for our clients and employees.

Prior to joining DLRC, James held positions at Deloitte and the European Medicines Agency. James has a BSc in Biochemistry from the University of Surrey and is currently pursuing an MSc in Regulatory Affairs.

Drew joined DLRC in 2022 and leads the technical and support team responsible for delivering best-in-class solutions and platforms not only internally to the business but also to our clients.

With over 25 years of experience in the technology field, he has worked in Formula One motorsport, media and public relations, digital transformation, and business data analytics. Focusing on the regulatory, pharma, and biotech space since 2018, he firmly believes that “the right tech, together with the right people, can deliver incredible results.”

Bina joined the company in 2024 and is responsible for leading the People Function, which includes People Operations, Talent & Learning and Development at DLRC. Since joining, she has set foundations in the team and has completed a number of projects to support operational efficiencies across the business.

Prior to joining DLRC Bina has over 20 years’ experience in HR predominantly in retail businesses including Healthcare varying for large organisations to start ups.

Bina is a Chartered Member of the Chartered Institute of Personnel & Development and holds an MA in Human Resource Management and a BA Hons in Human Resource Management with Business.

Laura's role involves driving DLRC's marketing strategy and managing the company's brand presence across all channels. Laura has over nine years of marketing experience and a proven track record of developing successful campaigns that deliver measurable results. Through her collaborative marketing approach, she develops strong relationships with clients and partners, working closely with stakeholders to understand their needs and create tailored marketing solutions that drive mutual success.

Laura holds a first-class BA (Hons) and an MA in Creative Direction with distinction. She has progressed into strategic marketing management, consistently demonstrating her ability to deliver innovative, multi-channel campaigns. As an Associate Member of the Chartered Institute of Marketing, Laura combines her creative background with technical marketing expertise to drive DLRC's continued growth in the life sciences sector.

Charlotte joined DLRC in 2021 after completing a degree in Politics and International Relations with Philosophy from the New College of the Humanities (now Northeastern University London). Upon joining the company, Charlotte was supported in completing Yale’s Corporate Sustainability Management: Risk, Profit, and Purpose course.

While at DLRC, Charlotte produced the company’s first Sustainable Impact Report, formed and led a team of Wellbeing Champions, and initiated several sustainability and wellbeing initiatives and policies. Charlotte also advises the Board, Operations, and Business Development Teams on decisions where sustainability is a key consideration.

Charlotte supports DLRC in being ahead of the curve in sustainable business practices, helping to resist potential shocks from new legislation that may affect DLRC or its clients.

Stuart is a Business Development Lead who joined DLRC in 2024. With over 20 years of expertise supporting clients across life sciences, healthcare, and social care sectors, including global pharmaceutical, biotech companies, and service providers, Stuart plays a key role in driving business growth for DLRC. His responsibilities include identifying new clients whose needs align with DLRC’s expertise while also maximising opportunities with the existing global client base. Leveraging the extensive knowledge of DLRC’s subject matter experts, Stuart ensures clients receive tailored regulatory, non-clinical, CMC, and clinical technical support. His focus spans clients developing medicinal and therapeutic products, MedTech innovations, and cosmetic/nutraceutical products.

Ankita currently serves as the Business Development Lead for Europe and the Middle East, coordinating the commercial strategy for DLRC's UK and EU offices. With extensive expertise in business development, partnership management, and the commercialisation of emerging technologies, she has spearheaded growth initiatives within the life sciences and biotech sectors. In her current role, her efforts are geared towards refining product-market strategies, forging strategic global partnerships, and assisting early-stage startups & mid-size Biotech/pharma in developing robust regulatory pathway approval strategies.

Ankita holds a master’s degree in Bioengineering from The University of Tokyo and has spent over five years navigating the Japanese business environment. With a deep understanding of both the commercial and technical aspects of biotech, she is committed to driving collaborations that accelerate innovation and foster global impact.

Liz joined the company in 2019 and has over 23 years of experience working in global regulatory affairs.

In addition to being a Team Leader, Liz has provided EU and US regulatory expertise to clients for various projects and therapeutic areas, including rare paediatric diseases. Support has included regulatory leadership, strategy and advice, Centralised MAA, and US BLA & NDA, global clinical trial authorisations, national, EU and US scientific advice and due diligence.

Prior to joining DLRC, Liz held positions in regulatory affairs at Mylan and Pfizer. Liz has a BSc in Biotechnology.

Kadi has been at DLRC since 2017 and has been working in regulatory affairs for over 17 years in a variety of roles and organisations, starting from working in a national health authority of her native country, Estonia, followed by generics companies in Cyprus and the UK and finishing with over 7 years to date working at DLRC. Kadi is skilled in EU and UK regulatory affairs, focusing on regulatory strategy, scientific advice, CTA applications, pre- and post-MAA submissions, and other types of regulatory authority interactions. The product types covered range from medical devices, generics, and drug-device combination products to novel small molecules and ATMPs.

Kadi has a BSc in Biology from the University of Tartu in Estonia and, whilst working for DLRC, achieved an MSc in Regulatory Affairs with distinction from the University of Hertfordshire.

Michelle has been part of DLRC since she joined the company as a graduate back in 2011. Since then, Michelle has worked with a variety of companies, large and small, mainly on focusing on clinical development activities with small molecules, biologicals and ATMPS. Michelle specialises in pediatric development and rare diseases but also has experience in oncology and infectious diseases. During her time at DLRC, Michelle also gained an MSc in Regulatory Affairs with distinction from the University of Hertfordshire and won the TOPRA award for Contribution in 2024.

Sharon joined DLRC in January 2022 with over 20 years of experience in nonclinical development, followed by 6 years in regulatory affairs. Focusing on nonclinical regulatory topics she supports clients at all stages of the product life cycle (from early phase development, Scientific Advice, PIPs, INDs, to MAA/NDA/BLA and post-approval procedures), across different research and therapy areas and has experience in the nonclinical regulatory aspects of both small molecules and biologics.

Prior to joining, Sharon held positions in contract research organisations, large pharmaceutical companies, and small biotech’s. Sharon has a BSc (hons) in Biosciences and Health.

Marianna first joined DLRC in 2020 and rejoined in 2023, bringing extensive experience in various therapeutic areas, including oncology and immunology, and complex products such as cell and gene therapies. At DLRC Marianna leads a team of regulatory consultants and supports clients from clinical development to marketing authorisation applications (MAAs) and life-cycle management. Marianna also contributes to the regulatory sector as a TOPRA Biotech, Cell and Gene Therapies SPIN member.

Prior to joining DLRC, Marianna held positions in biopharmaceutical companies and consultancies. Marianna has a BSc (Hons) in Physiology and Pharmacology from the University of Westminster.

Fiona joined the company in 2011 and during that time has taken on increasing line management responsibilities and is now Head of Regulatory Teams. Fiona has also provided regulatory expertise for clients including big pharma. This has included pre- and post-approval submissions, lifecycle maintenance and guiding clients through specific procedures such as Scientific Advisory Group interactions.

Prior to joining DLRC, Fiona held positions in regulatory affairs at GSK. Fiona has a BSc in Pharmacology from Bath University.

Indraj joined the company in 2021 and leads the MedTech Consulting team at DLRC. Indraj has over 12 years of experience in Medical Device Regulatory Affairs and Quality Assurance, having worked in industry and consulting roles. Indraj has supported clients during all phases of development, having successfully achieved CE Certification and 510(k) clearance for various devices across a wide range of therapeutic areas. Her expertise lies in strategic support, gap analysis, clinical evaluation, technical documentation creation, procedural support, device submissions and training.
Indraj has previously held positions at the MHRA, Stanmore Implants, Biomet, and Emergo.

Indraj has a MEng in Medical Engineering from Cardiff University.

David joined the company in 2019 following nearly 20 years at Pfizer and 5 years at Mylan. At Pfizer, David held the position of Director, EU Regulatory Affairs and at Mylan was the Senior Director and Global Team Lead for Respiratory Products.
At DLRC, David is a Senior Team Leader and has provided regulatory expertise to clients for various projects and therapeutic areas. David’s support has included MAAs, scientific advice and MHRA ILAP procedures.

David won the TOPRA 2022 award for Inspiration and has an MSc in Pharmaceutical Medicine.

Espe joined DLRC Ltd in 2018, bringing over 20 years of experience in regulatory affairs. Espe has successfully worked with multiple clients since joining DLRC.

Prior to joining DLRC, Espe worked in leadership roles for consultancy, generic and big pharma companies, where she developed a track record in project management, leadership, mentoring, training, and coaching. She is well versed in working with key stakeholders across key business units, supporting product lifecycle maintenance and business development.

Espe is a trained pharmacist with a BSc in Pharmacy from Navarra University in Spain.

Tim joined DLRC in October 2012 after 5 years in the UK Affiliate of Cephalon and 2 years of consultancy experience before that. The majority of his work has been in post-approval activities, including the creation of a dedicated team to handle the Global divestments for a top-five global pharma company (for which he won the TOPRA support award in 2021).
Tim has managed several colleagues starting in their Regulatory career and oversees the development of many more junior colleagues.

Tim has a PhD in molecular biology from the University of Sheffield.

Ian is a Principal Regulatory Consultant at DLRC. He is a Fellow of the Royal Pharmaceutical Society with a PhD in Pharmaceutics. He is now in his 40th year working in the pharmaceutical industry. He has worked in pharmaceutical development for 17 years, CMC technical leadership for 14 years, worked as a quality assessor at the MHRA for three years and is now in his 6th year at DLRC. He has developed and assessed many inhaled products such as Serevent, Flovent, Ventolin, Seretide and Relvar, to name a few. His experience sitting on three sides of the table as a medicine developer, regulator and consultant to medicine developers gives him a unique perspective and an ability to help clients understand how regulators think and develop strategies likely to succeed. Ian has an excellent record in navigating complex technical and regulatory issues. This record has been honed by many years of working on the propellant transition from CFC to HFA propellants in the 1990s and early 2000s and, more recently, helping DLRC's clients respond to challenging questions from regulators.

Catherine is a Principal Regulatory Consultant at DLRC, specialising in Chemistry, Manufacturing and Controls (CMC). Catherine has a B.Sc. in Chemistry and worked in radiosynthesis and analytical development before moving into Regulatory Affairs in the generics field 20 years ago, where she had her first taste of inhaled drug product registration. Catherine works with various clients at DLRC, advising on regulatory and CMC development strategy, authoring submissions and managing health authority interactions. She covers small molecules, biologics, ATMP, drug-device combinations and others across the product lifecycle. She has supported several inhaled product developments and brings a broad oversight of CMC regulatory and cGMP requirements.

Sarah joined DLRC in 2018 and has 17 years' experience in regulatory affairs. Her focus is mainly on EU and UK regulatory strategy and procedures both in the pre- and post-approval phase. At DLRC Sarah has provided support to several clients including managing PIP and scientific advice procedures for an antifungal well as lifecycle maintenance including an extension of indication procedure for an oncology product.

Prior to joining DLRC Sarah held positions at Gilead Sciences, Chugai Pharma Europe and Quintiles (now IQVIA). Sarah has a PhD in Chemistry from the University of Edinburgh.

Dawn joined DLRC in 2021 with many years of experience in Regulatory Affairs, with particular expertise in clinical development leading to MAA submissions, including advising on strategy for orphan drug designation, paediatric plans, scientific advice and regulatory authority interactions.

Most recently, while at DLRC, Dawn has worked with several clients to file MAAs to the MHRA, both as national MAAs and via the International Recognition Procedure.

Natasha graduated with a BSc in Medicinal Chemistry from Trinity College, Dublin and completed further Higher Diploma modules in pharmaceutical production. Natasha has a broad range of experience working in both the Pharmaceutical and Medical Device/IVD Industry for over 16 years with 11 years in Senior Leadership roles.

She has expertise in a wide range of therapeutic areas and proven track record managing Global Regulatory Affairs, Pharmacovigilance, Quality Assurance, Operations, Clinical and Medical Information, Research and Development and Project Management for Pharmaceuticals, Medical Devices, IVDs, Cosmetics and Foods working for SME and small companies, multi-national and Authorities such as the HPRA, LEO Pharma, Omega Pharma, Abbotts, Kora Healthcare and Beyond Air Inc.

She has been successful in directing the global strategy, gaining approval, and building the global footpath with registrations in over 150 countries in a wide range of therapeutic areas.

She was ultimately responsible for implementation of the MDR, IVDR, ISO 13485:2016, FDA, MDSAP, UDI, Serialisation, Brexit and other applicable legislation in her last few companies.

She is a member of the TOPRA MedTech working party and regularly asked to chair and speak at many conferences as a MedTech industry expert. She is a part-time Lecturer and assessor for BSc/MSc in Global MedTech modules for two universities in Ireland and the UK.

Heather joined DLRC in 2023 with over 22 years of Regulatory document and Submission publishing experience, 15 years within a Pharma company and 7 ½ years within a CRO environment working, on all types of submissions including Oncology, Infection and a Covid vaccine.

Heather works closely with DLRC project leads and our clients as part of the DLRC Regulatory Operations team, on all manner and size of Regulatory submission types across many Health Authorities.