Our Team

DLRC is a team of highly qualified and experienced experts, who have established strong working relationships with regulators, enabling the efficient realisation of client’s needs. Our team has extensive experience in regulatory procedures. This includes planning, authoring, reviewing, assembling, submitting, and maintaining documents required by regulatory agencies worldwide. With this extensive experience, DLRC is ideally placed to deliver full spectrum regulatory support throughout your product cycle.

Directors

Dianne Lee
BSc (Hons), FTOPRA, DipIoD CEO

Dianne founded the company in 2005 and has held responsibility for managing the business as well as project work during that period.

Prior to DLRC Dianne was an independent contractor for 10 years for many key pharmaceutical companies, Director of Regulatory Affairs at Serono UK, and worked at Schering Plough and SK&F.

Dianne is qualified in Applied Biology and holds a Diploma in Company Direction (Institute of Directors) as well as being a Fellow of TOPRA.

Kevin Judges
BSc (Hons), DipRegAff, FTOPRA Director of Business Development & Marketing

Kevin joined the company in 2009. In addition to overseeing business growth, has led regulatory teams in the successful delivery of complex regulatory filings. These Include centralised MAAs, orphan applications and scientific advice procedures.

Prior to joining DLRC he held positions of increasing responsibility within Global Regulatory Affairs at Roche.

Kevin has a BSc in Biochemistry, a post-graduate diploma in Regulatory Affairs from the University of Cardiff and is a Fellow of TOPRA.

Annette Delling
BSc (Hons), CBiol, MRSB, MTOPRA Director of Regulatory Quality & Principal Regulatory Consultant

Annette joined DLRC in 2016, taking on responsibility for 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.

Alisdair Falconer
MSci (Hons), PGCertReg Aff Director of Regulatory Consulting

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 Masters degree in Chemistry from Imperial College, London.

Chris Middleton
FCMA, ACMA, BA (Hons) Chief Financial Officer

Joining DLRC in 2022, Chris is responsible for all Finance related activities in DLRC. This includes budgeting and forecasting, strategic planning, liquidity and all accounting processes. Chris also has ownership of Information Technology and systems strategy and back-office operations.

Prior to joining DLRC Chris has over 25 years experience of finance across different sectors including healthcare outsourcing, consulting, supply chain & 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.

Cheryl Dhillon MBA
FCCA, MBA, BA Non-Executive Director & Board Chair

Cheryl joined DLRC in October 2022.

Cheryl is a senior executive with extensive experience in a variety of sectors. Cheryl has a number demonstrable achievements in business strategy and P&L optimisation in start-up, growth phase and major transformations. Through her long 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 development of people and to this end has trained as an Executive coach with 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 which fit her interests and are value adding 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
PhD Managing Director & Head of Regulatory Affairs, Orphix Consulting GmbH

Wafa Bouaziz is the Managing Director and Head of Regulatory Affairs at Orphix, DLRC Group’s EU company.

Wafa joined Orphix in April 2017 and has been leading the team in Germany, since December 2018.

She is a global regulatory professional with a broad experience across various therapeutic areas including rheumatology, anti-infective, dermatology and oncology. She has a 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 with regulatory procedures including orphan drug designations, orphan maintenance, PIPs, scientific advice, MAA and BLA.

Wafa is a pre-clinician by background and has a PhD in Molecular and Cellular Biology from the University of Paris Diderot (France).

Greg Dombal
BS President, DLRC Inc.

Greg joined DLRC in 2023 and is the head of DLRC Inc. the US subsidiary of the DLRC Group. He is responsible for the DLRC’s growing US business – managing clients and staff. His office serves as the US Agent for many of DLRC’s worldwide clients who do not have a US business presence.

He began his career in 1994 with Burroughs Wellcome and a broad pharmaceutical, biotech and MedTech business career. He has extensive experience interacting with FDA and other regulatory agencies and received approval for multiple products. He has led Regulatory, Clinical and Quality teams, managed global alliances for Product Development, co-founded several biotech companies and led a boutique consulting firm. This wide experience allows him to design and implement regulatory strategy in lockstep with business demands resulting in efficient and patient focused product development.

Greg has a degree in Biology from the University of North Carolina at Chapel Hill and holds a change management professional certificate from Colorado State University.

Management Team

Indraj Bamrah
MEng Principal Regulatory Consultant & MedTech Team Lead

Indraj joined the company in 2021 and is responsible for leading 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. She has supported clients during all phases of development, having successfully achieved CE Certification and 510(k) clearance for a variety of 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.

James Biddlecombe
BSc (Hons) Business Transformation Manager & Clinical Trial Regulation (CTR) Lead

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. He 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, he 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 studying for a MSc in Regulatory Affairs.

Sacha Lynch
MSc Principal Consultant & Senior Team Lead

Sacha joined DLRC Ltd in 2021, with over 20 years of experience in regulatory Affairs. Supporting clients from late phase developments and providing strategic advice, scientific advice, PIPs, MAAs through to post approval maintenance.

Prior to joining DLRC, Sacha has gained experience with several small pharma companies, working with cross functional teams and with regulatory consultancies.

Sacha has a master's in clinical research management from Cranfield University and a degree in medical sciences from the University of London.

Liz Morgan
BSc (Hons) Principal Consultant & Senior Team Leader

Liz joined the company in 2019 and has over 20 years of experience working in Global Regulatory Affairs.

In addition to being a Senior Team Leader, Liz has provided regulatory expertise to clients for a variety of projects and therapeutic areas. Support has included Regulatory leadership, strategy and advice, Centralised MAA and US sBLA, 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.

Fiona Bright
BSc (Hons) Head of Regulatory Teams

Fiona joined the company in 2011 and during that time has taken on increasing line management responsibilities and is now Head of our 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.

David Sudworth
MSc Principal Consultant & Senior Team Leader

David joined the company in 2019 following nearly 20 years at Pfizer and 5 years at Mylan. At Pfizer David was a director, EU regulatory affairs and at Mylan 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 a variety of projects and therapeutic areas. Support has included MAAs, scientific advice and MHRA ILAP.

David won the TOPRA 2022 award for Inspiration.

David has an MSc in Pharmaceutical Medicine.

Jerry Young
Head of Business Development

Jerry joined the DLRC in 2020, bringing with him over 30 years' experience in Business Development within Regulatory Affairs. Jerry has a strong and proven track-record of full service CRO Business Development. His experience includes both the areas of non-clinical and clinical research, within biotech and pharmaceutical companies globally.

In his current role as Head of Business Development, Jerry engages with new clients to understand their project requirements and how DLRC can offer the optimal support. He has a specific focus on Bio-Hubs across the UK, Europe, North American and Asia Pacific. In addition, Jerry maintains existing clients through the lifecycle of their asset development, to ensure project continuity and support of long-term clients.

Before joining DLRC, Jerry was the Director of Business Development for the Quality and Compliance Consulting team at a leading CRO Syneos Health.

Espe Avello
BSc Principal Consultant & Senior Team Lead

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

Prior to joining DLRC, she 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 as well as being well versed in working with key stakeholders across key business units supporting product life maintenance and business development.

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

Tim Beaujeux
PhD Principal Consultant & Senior Team Lead

Tim joined DLRC in October 2012 after 5 years in the UK Affiliate in 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 5 Global Pharma company (for which he won the TOPRA support award in 2021).

Tim has managed several colleagues starting out in their Regulatory career and currently oversees the development of many of the more junior colleagues.

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

Join the team

As DLRC continues to grow through referrals and reputation, we are always looking for talented and dynamic regulatory affairs professionals to join our team.

Careers

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