Regulatory Affairs Manager

Highly Competitive
  1. Permanent
  2. Project Manager
  3. United Kingdom
Cambridge, England
Posting date: 17 Dec 2020

A vacancy for a Regulatory Affairs Manager has become available at a privately-owned biotechnology company based in Reading. The Company researches and develops the worlds most advanced galacto-oligosacharide (GOS) products, providing solutions for Food and Healthcare companies across the global Wellness market as well as marketing to consumers under a brand name.

Job Responsibilities

Lead on Regulatory issues including:

  • Registration applications for product, health claims and enzymes in global markets, specifically working with Regulatory Authorities such as EFSA and FDA
  • Internal point of contact for regulatory input into project work/campaigns/partnerships
  • Inform internal stakeholders on any potential effects on the business identified through horizon scanning
  • Achieve regulatory compliance internally for all external materials via the Marketing Approval Program (MAP)
  • Active involvement in external Food law (IFST) and Trade Associations (FDF) to help shape legislative decisions and to gain up to date information about regulatory changes

Required Skills and Experience

  • A background in food and food supplements, preferably in ingredients with a business to business focus
  • Ideally have experience in the European, US and Asian markets
  • A strong network in the regulatory field
  • Excellent communication skills - both written and oral
  • Strong interpersonal skills with a proven ability to develop and maintain strong relationships
  • A team player with a strong desire to achieve
  • Strong analytical skills with the ability to identify and solve problems
  • Strong strategic capability combined with a desire and willingness to be hands on in this role
  • Related or relevant industry sector experience

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.