Regulatory Affairs Specialist for Nutrition and Health Products

6 days ago


Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

About the Job


We are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group in the UK. As a key member of our regulatory affairs division, you will play a crucial role in ensuring compliance with UK and European regulations for nutrition and health products.


Responsibilities:



  • Review product formulations and labels to ensure compliance with UK and European regulations, including food supplements, general foods, and novel foods;
  • Making recommendations to clients on how to alter their products to meet regulatory requirements while considering business and scientific objectives;
  • Reviewing health and nutrition claims according to FSA/EFSA guidance, including approved and on-hold claims lists, and providing expert opinions on substantiation;
  • Developing and submitting novel food dossiers to authorities, answering questions from authorities as needed;
  • Providing regulatory assistance at all stages of product development for medical devices, including feasibility assessments, device classification, design, risk assessments, PMS, and technical file preparation;
  • Advising clients on regulatory and quality matters related to nutrition and health products;
  • Creating regulatory strategies for market access for a range of nutritional and health products in the UK and Europe;
  • Staying up-to-date with relevant regulatory guidelines and interpreting them for clients;
  • Drafting regulatory framework documents and assisting in regulatory submissions in the UK and European countries;
  • Communicating with clients through calls to present work and answer questions;

Requirements


To be successful in this role, you will need:



  • A Bachelor's Degree in human nutrition, food science, or a similar field;
  • At least 7 years' experience in regulatory affairs working on a range of nutritional products in the UK and Europe;
  • Strong knowledge of UK and European food regulations, as well as regulations regarding self-care medical devices, cosmetics, herbal medicines, biocides, and borderline products;
  • Excellent organizational and interpersonal skills, with fluency in English;
  • Ability to prioritize tasks, work independently, and deliver high-quality results under tight deadlines;

What We Offer


As a Regulatory Affairs Specialist at ProductLife Group, you can expect a competitive salary of £65,000 - £80,000 per annum, depending on experience, plus benefits and opportunities for professional growth.



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