Phynova Group Ltd is a specialist life science companh that develops healthcare products from the plants used in traditional Chinese medicine (TCM). The company works extensively with collaborators and research partners in China in developing its innovative products.

This is an exceptional opportunity for an ambitious individual who wants to make a significant impact in a business with extraordinary growth prospects that has products just starting their product life-cycle as regulated medicines, as well as products just about to under-go regulatory filings in multiple geographies. This role has a significant focus on the registering products as new OTC drugs with the MHRA under the Traditional Herbal Medicinal Product directive (THMPD), but also includes making applications for new health clains with EFSA, as well as GRAS and novel food filings in the USA, EU, China, and India. in addition to a sound understanding of the regulations pertinent to medicinal plants and food ingredients, a sound understanding of TCM and biological / medical sciences (e.g. pharmacy, pharmacology, biochemistry) is essential, as an important part of the role is helping to identify new product opportunities from the plants used in TCM that are compliant with the relevant legislation and can be put through the regulatory processes of the THMPD.

-   To support the R&D team with researching and compiling CTD for existing OTC drug applications under the THMPD. This involves activities including but not limited to:

-   Conducting systematic reviews of the relevant Chinese and Western date-bases to support safety and efficacy claims, including translating relevant Chinese literature into English

-   Managing out-sourced CMC and safety toxicology studies

-   Compile dossier in accordance with relevant regulatory formats

-   To research the plants and formulas used in TCM for new product opportunities that are compliant with the THMPD and can meet the supply, analytical, toxicology, and evidence of use requirements to make a viable OTC drug in the UK. This includes translating TCM theory into western medical parlance

-   To provide regulatory support and dossier compilation or novel food applications in Europe, China and India and USA, ensuring that any supporting activity, toxicology or CMC studies are designed and conducted within the regulatory frameworks for the appropriate national authority

-   To provide regulatory support and dossier compilation for health claims applications in Europe

-   To support Phynova's Beijing subsidiary in applications for Chinese Novel foods, health-food products, and other regulatory filings, including reviewing and translating relevant English literature into Chinese

-   Medical writing for the all regulatory dossiers or academic articles. This will include translation from Chinese literature to English or vice-versa

-   Management of research CROs (placing work orders, reviewing quotes and technical agreements, progress monitoring, protocol and draft report review) conducting work in support of the various regulatory applications

-   Assistance in developing and maintaining strong relationships with the business and research partners in China (companies, universities and research institutions) in key focus areas (e.g.pharmaceutical, medical device, food and drink, supplement, medical food industry)