Job Description

To strengthen our scientific and regulatory affairs team, our Business Unit Medtech and Consumer Health is seeking her/his Senior Regulatory Affairs Principle Consultant with an in-depth experience working on Nutrition and Consumer Healthcare products.

The candidate will have 12-15 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.

An additional expertise in medicinal or consumer healthcare products (medical devices, pharmaceutical products) is requested.

An experience in National Food & Beverages Associations, Local Food or Drug Agencies is valuable.

Monthly business trips in Angers and in Paris.

 

Group 10
Your main responsibilities will be

  • Regulatory Strategy for innovation, advocacy, future regulatory challenges in the field of nutrition, foodstuffs, consumer healthcare.
  • Collaboration with R&D, Regulatory affairs, Marketing, CMC, Strategy departments of our customers
  • Project management for innovative products/ingredients (from R&D to local marketing authorization). Making recommendations and advising clients during product development stage to be compliant in the EU considering the business and scientific objective of our clients
  • Team/Expert Project management
  • Project management of marketing authorization requests
  • Regulatory strategy for market access for range of nutritional and healthcare products
  • M&A : coordination of due diligence (presentation of executive summary, expert session, closing)
  • Negotiation Public Affairs and lobbying with European or local authorities
  • Identify and interpret relevant regulatory guidelines
  • Relationships with National Associations

Group 12
You will have the following skills and qualifications

  • Degree in human nutrition, food science, food law or similar (chemistry, biology, Ph D Medicines, Ph D Pharmacist)
  • Experience with EU food and Consumer HealthCare Product regulations (> 12 years)
  • Experience on different regulatory status is requested
  • High level of expertise
  • Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel.
  • Both French and English fluent (written and spoken).
  • 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, leader mindset

Principle Regulatory Affairs Project Manager for Nutrition Products - 377

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