- Carrying out formula and label reviews for nutritional products including food supplements, general foods, foods for special medical purposes) to the applicable UK and European Regulations Examples of ingredients include vitamins, minerals, botanicals, solvents, additives, excipients, natural extracts, etc.
- Making recommendations and advising clients on how to alter product formulations and labels to be compliant in the UK and Europe considering the business and scientific objective of our clients.
- Review health and nutrition claims according to FSA / EFSA guidance by reviewing approved claims list and on-hold claims lists and if necessary reviewing scientific data to substantiate claims.
- Writing novel food dossiers, submission to authorities and answering questions from authorities.
- If expertise in medical devices, providing regulatory assistance at all stages of product development to CE/UKCA marking (feasibility assessments, device classification, design & conception, risk assessments, PMS and writing different parts of the technical file according to MDR 2017/745).
- Advising on all regulatory and quality questions relating to nutritional and health products.
- Develop regulatory strategies for market access for range of nutritional and health products in the UK and Europe.
- Identify and interpret relevant regulatory guidelines.
- Drafting regulatory framework documents.
- Assisting in regulatory submissions in the UK and European countries.
- Attend client calls to present work and answer questions. Group 11 Education
- At least a Bachelor's Degree in human nutrition, food science, or similar. Group 12 Experience
- At least 7 years' experience in regulatory affairs working on a range of nutritional products (food supplements, ingredients, general foods, foods for special medical purposes, novel foods and additives) in the UK and Europe. Group 13 Skills
- Knowledge of UK & European food regulations is required
- Knowledge of regulations regarding self-care medical devices, cosmetics, herbal medicines, biocides and borderline products is ideal but not mandatory
- Knowledge of US' regulatory affairs is also beneficial but not mandatory.
- Good IT skills/knowledge including proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel.
- Fluent English is required
- Excellent organizational and interpersonal skills
- Excellent oral and written communication skills, including facing the client
- Ability to work independently and autonomously with minimal supervision, and as part of a team.
- Ability to prioritize different workloads/multi-task
- Ability to deliver on tight timelines
- Personal responsibility for ensuring a high standard of work
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Regulatory Affairs Consultant for Nutrition and Health Products M/F - Cambridge, United Kingdom - ProductLife Group
Description
About the job
To strengthen our regulatory affairs division in the UK and Europe, RNI (a ProductLife Group Company) is urgently looking for a Regulatory Affairs Consultant with experience working on nutrition & health products in the UK and Europe.
About us Group 10 ResponsibilitiesThe candidate will have 7+ years' experience in regulatory affairs with demonstrated experience working on a range of nutritional products (food supplements, ingredients, general foods, foods for special medical purposes, novel foods and additives) in the UK and Europe.
Experience in other industries will also be beneficial as you could also be working on self-care medical devices, cosmetics, herbal medicines, biocides and borderline products. Experience in USA regulatory affairs is also beneficial but not mandatory.
Your responsibilities will include:
Hard/Technical skills:
Soft skills:
