Consultancy Career Experience: Nutrition, Regulatory & Scientific Affairs
Infant Nutrition, Food for Special Medical Purposes, Medical Devices & Food Supplements
Senior Regulatory Affairs Manager UK & IRL Specialised Nutrition DANONE
(2023 – 2024) Infant Formula, Food for Special Medical Purposes, Baby Foods, Medical Devices & Food Supplements
Achievements and responsibilities:
- Responsible for the regulatory management of UKI Food for Special Medical Purposes (FSMP adult & paediatric) to include metabolic, ketogenic and allergy, infant nutrition, baby foods and medical devices portfolio.
- Support medical device UKCA/MHRA application.
- Five direct reports: support personal development and objective strategic planning.
- Built regulatory advocacy plans in conjunction with Public Affairs and other relevant functions, execute plans to advocate Danone’s positions towards local governmental and industry bodies when specific business interest should be promoted or defended.
- Monitored, shaped, and communicated changes in regulations, interpretations, and new regulations.
- Engaged with trade associations and government agencies (i.e. FSA, FSAI, ASA, ASAI, TS, DHSC) on technical matters. Coordinated the appropriate definition and application of positions, guidelines, policies, pledges, and commitments.
- Product compliance and innovations, lead a team to enable innovation & renovation projects by bringing regulatory expertise, interpretations, guidance & solutions.
- Provided regulatory direction in the NPD process, ensuring market compliance for products developed by the Global Innovation department, leading to successful product launches in the UK and EU.
- Designed and executed the short- and long-term regulatory strategy to support relevant categories.
- Acted as a champion of the Claims Validation Management (CVM) process and lead complex regulatory risk assessments.
- Coordinated responses to queries/challenges from competitors or regulatory bodies.
- Internal interactions: Medical Affairs, Marketing, Legal & Compliance, Public Affairs, Sustainability, Quality and Food Safety, Sales, Supply Chain and Global Regulatory affairs.
- External Interactions: Trade associations, regulatory authorities, competitors.
Regulatory Affairs Manager UK & I SMA Nutrition, Nestle Nutrition Hybrid
(2021 – 2023) Infant Formula, Food for Special Medical Purposes, Baby Foods & Food Supplements
Achievements and responsibilities:
- Regulatory compliance review and support to Brand, Marketing, CDT, Shoppers for all Assets to include new packaging, websites (consumer and HCP) UK and Ireland, TVC, articles (external and baby club), banners, conference materials, educational materials (HCP), influencers brief and content, social media posts (Facebook, Instagram, TikTok, Pinterest),
- Regulatory review of all new recipe’s composition, additives and permitted nutrition and health claims in line with current legislation for Infant Formula, Follow on Formula, Growing Up Milks, FSMP’s, Food Supplements and Baby Foods.
- ACBS submissions: for five paediatric products Type 1-3 applications.
- Working member of BSNA infant nutrition and medical foods working group, Dairy Industry Ireland (DII) technical working group and Health Food Manufactures Association (HFMA) technical working group: attend monthly meeting, attend ad hoc meetings on key issues/ updates to new bills, regulations, and legislation to include assessment of impact on category. Compilation and review as a member of letters to respond to DHSC or relevant party.
- Horizon scanning, identifying key impact on business and providing feedback to the team in an easy-to-understand context.
- Assessment of non-compliance of competitors on pack, online or baby show materials. Providing information to trade association for assessment and plan of action.
- Training internal new starters, refresher training and external training (agencies) on WHO Code, infant nutrition regulatory restrictions, and internal approval process.
- Reviewing current SOPs and amending to current legislation and team requirements.
- Member of sustainability board: key person to approach on review of assets with sustainability messaging in line with current national policy and internal Nestle policy.
Regulatory Manager LATAM, MEA & E.Eu Bountiful Company, Nestle Health Science London & Home Based
(2020 – 2021) Food Supplements
Achievements and responsibilities:
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- Regulatory support in South America, 29 countries with 56 distributers, Middle East & Asia, Russia, Turkey & Ukraine: technical queries and technical documentation to support and include registrations; renewals; import permits supporting documentation; NVA, GMO letters, veterinary certificates, Zone IVB stability study review, Zone II stability studies, certificates of free sale, GMP’s, organic certification, change control supporting documentation.
- Manuscript & Label Compliance: Food label proof checks enabling optimisation of food label changes to meet current legislation in South America, Middle East & Asia, Ukraine, Russia and Turkey.
- Innovation regulatory lead for supplement range sold into countries with low upper limits or restrictions on ingredients. Compliance review of formula, liaise with PD on FPIFS for approval and collation of correct technical documentation to support internal PIF, label and external registration process. Updates with brand and project team on progress of project.
- Horizon scanning for updates, publications releases & changes to legislation with impact assessment for product portfolio. Delivery of presentation to provide a summary to commercial, brand, quality, technical and regulatory team on impact of pending and current legislative changes to product portfolio.
- Internal compliance reviews – Innovation and NPD, review of upper limits in countries to be sold into; allergen review, changes to product specifications or out of spec issues, colours review, Ti02 removal and ingredient substitutes; change controls impact to labels, PIFS or specifications.
- Impact assessments to changes to label contents, packaging, ingredients or shape of product in complex regulatory environments for 56 distributers in South America covering 29 countries.
- Support direct report with additional technical expertise in Middle East and Asia and Eastern Europe.
- Bottle consolidation project; Packaging reduction projects.
Nutrition Consultant, Neal’s Yard Remedies, Dorset & Home Based
(2015 – 2020) Food Supplements, Botanicals, Food Safety Management Systems, NPD
Achievements and responsibilities:
- Label Compliance: Food label proof checks enabling optimisation of food label changes to meet current legislation.
- Review of existing supplement range in line with current literature, analysis of ingredients with recommendations.
- Research and innovation of natural health market forecast on new ingredients or targeted health trends for advice on new product development.
- Food label checks review compliance against the UK European Food Information to Consumer Regulation (FIC), EU No.1169/2011 and product specific legislation including on pack nutrition and health claims Regulation (EC) No 1924/2006.
- Development of training material for all staff covering multiple departments depending on job on new product training.
- Development of training material for all staff covering multiple departments on HACCP and allergen management.
- Internal food allergen risk assessment and compilation of technical documentation of HACCP and allergen management plan for natural health products.
- Raw material specification maintenance and managing updates from large supply base.
- Supplier approval documentation maintenance – reviewing SAQs and BRC certificates, reports and updating master files to maintain the information.
- International Customer Service support on natural health product queries.
- NPD – Design & Development of Natural Health Programme for weight loss and stress support and supplements.
- Author of support material for new products – Fibre Blend; Men’s Supplement and Pregnancy Supplement.
- Critically appraise the literature connected to media press release in relation to Natural Health Products.
- In house lunchtime nutrition talks as part of wellness and mental health awareness weeks.
Food Industry
Interim Specifications Technologist
Working within the technical department for a manufacturer that produces both sweet and savoury bakery products for major retailers such as M&S, Waitrose, Tesco, Sainsbury’s, ASDA, Co-op, Morrison’s and Fortnum and Mason. Directly interfacing with many departments and outside bodies including retail customers and material suppliers.
- Using raw material and packaging information to create finished product specifications for their retail customer base and own brand.
- Artwork reviews with Head of Technical to ensure that pack copy met legal requirements and labels were correct for their intended use.
- Artwork review using retail online artwork approval such as M&S Graphics Approver and Waitrose OB1.
- Working on multiple critical paths to customer requirements. Critical Path compliance – specification creation through to artwork approval.
- Convert NPD recipes into controlled technical recipe to include bake loss calculations
- International raw material queries for export.
- New ingredient raw material specification maintenance. Compliance to retail approved supplier lists.
- Implementing procedures to improve the flow of information. Actively involved in improving internal product data information system for own brand and retail customer.
- Customer relations and first hand communication with customer technologist, NPD, Artwork House and Printers.
Interim Specifications Technologist & Assistant Technical Manager
Working within a very busy technical department for a chilled and sterilised ambient food manufacturer that produces premium products for major retailers such as Waitrose and Tesco and high street restaurants such as Pret a Manger. This includes chilled soups, sauces, stocks and gravies as well as ambient retort sterilised soups, sauces, stocks and gravies.
Employed on an interim basis to cover various aspects of the Assistant Technical Manager’s role. On appointment of a new Assistant Technical Manager, the role changed to looking after FIR changes for retail labelled packs produced within the company. The aspects involved working on specifications for a Waitrose launch and a Tesco launch.
- Raw material specification maintenance and managing updates from large supply base
- Supplier approval documentation maintenance – reviewing SAQs and BRC certificates, reports and updating master files to maintain the information.
- Working with the Head of Technical on new supplier approvals for Tesco and Waitrose launches
- Using raw material and packaging specifications to create finished product specifications for Waitrose and Tesco. Systems used were micros based online specification systems such as TTL for Tesco and WRspec for Waitrose.
- Artwork reviews with Head of Technical to ensure that pack copy met legal requirements and labels were correct for their intended use.
- Assisted technical department in preparation for customer and 3rd party audits.
- Produced detailed monthly technical reports for key customers including Waitrose and Pret a Manger. This involved collating all of the relevant data drawn from various resources and colleagues.
- Produced various internal technical and quality reports for the quality communications board for the factory. This included reports on customer complaints, environmental hygiene, GMP issues and status of non-conformances and non-conformance trends within the business.
- Updating 50+ existing finished retail product specifications to meet FIR requirements and submitting the specifications to collaborative draft before setting to pack copy sent. Reviewing and commenting on FIR amended artwork against the agreed pack copy before final approval and file to print stage.
- Successfully completed within a very limited time frame against a tight critical path for 12 Tesco Specifications to gold standard created from scratch on TTL for launch due in autumn 2014.
Delivery of Seminars/Talks
Nutrition and Well-being based – to schools, groups and workforce’s, to make positive, practical changes to their food choices and general health
Author, Dorling Kindersley
(2015 – present)
Achievements and responsibilities:
- Co-author on three books: Natural Mother & Baby, Eat Beautiful and Wellbeing. To include critically appraising the literature to provide current information on relevant subjects provided in the brief.