Bethany Dean

Bethany Dean - Curriculum Vitae - --- Education University of Warwick, Coventry, UK Master of Chemistry, Grade achieved 2.1 2013 to 2016 King Edward VI Sixth Form College, Nuneaton, UK A-levels: Maths (A*), Further Maths (A), Chemistry (A), Biology (B) 2010 to 2012 St Thomas More School & Sixth Form College, Nuneaton, UK GCSE’s: 11 A*, 1A 2005 to 2010 North Warwickshire & Hinckley College, Nuneaton, UK Professional Scholarship: Law (C) 2008 to 2009 Previous Employment Global Head of Regulatory Affairs – De Faire Medical Feb 2022-Current Responsible for delivering end to end compliance for the De Faire Medical portfolio. Key activities include product registration, distributor set up, artwork creation, dossier creation and maintenance. Covering all EU markets, GB, US and rest of world markets in particular Middle East and South America. Actively involved in company strategy as part of the leadership team. Regulatory Affairs Manager – PDI Ltd August 2021-Feb 2022 In charge of the regulatory affairs team within PDI Ltd covering both the Corby, UK and Milan, Italy site. Ensuring all products within our brand portfolio and the contract manufacturing portfolio remain complaint and maintained on the market. Key activities involve filing necessary applications for new product launches, variations to existing registrations and advising our customers on their regulatory strategy for the contract manufacturing side of the business. All activities cover the following classification: detergents, cosmetic, biocides, medical devices, and medicines. In addition key projects involve the MDR transition, medicinal registration, Brexit transition and BPR registrations. Assigned RP contact person for cosmetics. Regulatory Specialist Consultant - TCS - Client DePuy Synthes November 2020-July 2021 Employed as a consultant and technical expert on Regulatory affairs matters, specifically for Russia but also covering all world markets. Provide independent regulatory guidance on dossier preparation and regulatory strategy to meet project timelines. Work collaboratively with the wider team to lead the new registration submissions and remediation activities whilst training the regulatory team on the processes that need to be followed for Russia registrations to widen their knowledge. Global Regulatory Associate – RB - Sexual Wellbeing Category November 2019-October 2020 Work within the Global Regulatory Sexual Wellbeing Category team to define and implement the regulatory strategies for Durex and KY, within agreed timescales to bring a competitive advantage to the RB portfolio. Working collaboratively with R&D, Quality, Medical, Clinical, Supply and Marketing functions along with the country regulatory teams to launch and rollout new products of different classifications: Medical Devices (MDR and MDD – all classifications), General Products and Electrical Products to a wide range of markets specially EU, LATAM, ASEAN and USA. Global Regulatory Associate – RB - Market Expansion July 2018-November 2019 Sexual Wellbeing Lead in the Market Expansion team delivering new products across the globe within the Durex and KY portfolio. Current responsibilities involve delivering end to end registrations of condoms, lubricants and toys in ENA and DvM markets, ensuring bespoke technical files are delivered for each market. Alongside product registrations other key responsibilities are working cross functionally with the new product development and compliance team to deliver a holistic sexual wellbeing portfolio to the market, having oversight of all deliveries not executed by myself, managing responses to health authorities and managing the country insights database to maintain knowledge of local requirements within the team. Alongside the Sexual Wellbeing portfolio, I manage the roll out of Gaviscon Infant into DvM markets, maintaining both medical device and medicinal regulatory knowledge and expertise. RB Future Leadership Programme (FLP) September 2016-June 2018 As part of the RB FLP scheme I have gained experience in 3 different R&D functions within a two year accelerated development programme. 1. Gaviscon Category Formulation Associate (12 months) Technical project lead on two new innovations within the Gaviscon team to work towards step changing the consumer experience within the digestive relief category, together with regaining speed and momentum on a long-term project for a new mode of action for the brand. Alongside the project delivery I developed and implemented a sustainable innovation process within the category team to help with both the brand pipeline to address business unmet needs. Also I included personal development training sessions within the innovation process to build the teams soft skills and create a more innovative and versatile team dynamic. 2. Research & Development Operations Associate – Homecare (6 months) Project manager and technical project lead on the slow release and passive portfolio of the homecare category. I was responsible for the delivery of one major net revenue protection project to protect the whole candle portfolio, which was delivered within a 5-month timeline. This involved end to end project management, stakeholder engagement and line management of the YII student to successfully deliver this project within strict deadlines. In addition, I was responsible for supporting the homecare factories in China and Tatabanya, delivering television copies to the UK marketing team and initiating an existing product development within the candle portfolio to address a consumer unmet need. 3. Global Regulatory Associate – Market Expansion (3 months) Regulatory Project Lead working on specifically the Nurofen and Gaviscon brand. Currently delivering the roll out of the Nurofen Medicated Patch into 16 new European markets with exploratory work for the roll out into the developing markets. In addition, working on the feasibility and delivery of the roll out of the Gaviscon brand worldwide. To supplement the delivery of the roll out initiatives, I am working on developing a best practice country insight index to develop the expert knowledge within the team. This then will be shared business wide to educate the cross functional teams in the roll out regulatory requirements so this can be captured initially at the innovation and brief stage of a project with the long term aim of saving resource and time at post launch stage. Experience Monash University - International Conference of Undergraduate Research (ICUR) September 2015 Following on from the two previous summer projects and the publication of the research paper in Biomacromolecules a scholarship was awarded by IATL to fund an overseas conference at Monash University where the research I have completed was presented at an international conference alongside experts in the industry and key influential professors. Warwick University – Easter Research Project March 2015 A 4-week research project following on from the summer internship as part of the Gibson Lab Group. Funding received from Materials GRP to further the work. Also, awarded IATL research funding, which was not required for the research project. Warwick University - Summer Research Project A 12-week research project throughout the summer as part of the Gibson Lab Group. Research in ice nucleation and polymer characteristics to fundamentally reduce the initiation sites through high spec microscopic measurements and analytical techniques. Received two bursaries to fund this project – Royal Society of Chemistry Undergraduate Research Bursaries and Materials GRP Summer Bursary Programme. In addition, I am completing the Undergraduate Research Support Scheme to run alongside this research project Publications Congdon, T., Dean, B.T., Kasperczak-Wright, J., Biggs, C.I., Notman, R., Gibson, M.I., 2015, Biomacromolecules, Probing the Biomimetic Ice Nucleation Inhibition Activity of Poly(vinyl alcohol) and Comparison to Synthetic and Biological Polymers June 2014 Royal Society of Chemistry - Horizon Prize – Interdisciplinary chemical approaches to understanding cryobiology – Chemistry Biology Interface Division Horizon Prize: Rita and John Cornforth Award – June 2022