Rhys joined Broughton having previously worked in regulatory applications, compliance, and product characterization science for e-cigarettes and pharmaceuticals.
- Part of the team submitting the first successful Marketing Authorisation Application for an e-cigarette-based product.
- Over 10 years of experience in nicotine product science and regulation and how these have developed over time.
- Active involvement in standardization working groups for a wide variety of products and requirements.
- Part of the Scientific Affairs team at Broughton, working on regulatory submissions of all kinds and developing the supporting product science for a variety of next generation products.
Rhys Wadkin is part of the Scientific Affairs team at Broughton. He is fortunate to have been involved in the science and regulatory aspects of electronic cigarettes and next generation nicotine products in general almost from their introduction (starting in 2011). Originally from a pharmaceutical quality compliance background, he has seen the regulatory environment grow from no regulation at all to the position we are in today and has been involved for nearly the whole journey.
Early in his career, Rhys worked in pharmaceutical Quality compliance, managing quality management systems, and conducting internal and external audits to ISO 9001 and GMP, followed by a period of contracting the same services - working closely with a contract QP in developing quality management systems for small and start-up pharmaceutical companies to meet regulatory requirements.
Rhys joined the small team at CN Creative in 2011 - a small start-up company to achieve the first successful marketing authorization for an electronic cigarette in the EU. A product category that at the time had no benchmark and very few published scientific works or methods to reference and was directly involved in the quality management system set-up, MHRA audit, and compilation of both the MAA and Technical File.
Rhys joined Nerudia in 2016, initially working as part of the science and regulatory team. His responsibilities involved client consultation on TPD2 requirements, Marketing Authorisation Applications, and scientific support on novel Innovation products developed on site. Following the acquisition of Nerudia by Imperial
Brands, Rhys became part of the internal Product Characterisation Science team, covering all aspects of characterization science for NGP nicotine products. This involved supporting regulatory applications for internal products (TPD, PMTA), stewardship, and assessment of potential new products (either purchased or internal Innovation).
Since 2018 Rhys has been involved as a member of BSi in the development of new standards for CEN/TC/437, participating actively as an expert in working groups developing standards on nicotine consistency, direct-to-lung vaping parameters, and Extractables and Leachables.