Specific activities and responsibilities:
To strengthen our scientific and regulatory affairs team of the Business Unit Nutrition, we are seeking a Regulatory Affairs & Innovation Project Manager with experience working on nutrition products at international level.
The candidate will have 8+ years’ experience in regulatory affairs / project management with demonstrated experience working on a range of nutritional products (Novel Food, Functional food, food supplements, Foods for specific groups) in Europe.
YOUR MAIN RESPONSIBILITIES WILL BE
- Project management for innovative products/ingredients
- Project management of marketing authorization requests (including novel foods & new additives authorizations, consultation process, new health claims applications, etc.)
- Product development with coordination with CMOs, suppliers, labs, authorities. Making recommendations and advising clients during product development stage to be compliant in the EU considering the business and scientific objective of our clients
- Regulatory strategy for market access for range of nutritional and health products
- Regulatory compliance of newly developed, innovative foods, foods produced using new technologies and production processes, as well as foods that are or have been traditionally eaten outside of the EU.
- Review of scientific dossiers (i.e. health claims substantiation dossiers).
- Identify and interpret relevant regulatory guidelines.
- Drafting regulatory framework documents
- Expertise and experience in non European regulations are required (Asia, Latam) (and in addition to European expertise)
YOU WILL HAVE THE FOLLOWING SKILLS AND QUALIFICATIONS
- Degree in human nutrition, food science, food law or similar.
- Experience with EU food regulations (experience with Novel Food applications would be appreciated)
- Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel
- Ability to manage projects, to work independently with minimal supervision, and as part of a team.
- Desired qualities: autonomy, flexibility, communication, technical writing, team mindset.