Senior Regulatory Affairs Specialist (H/F)

  • 59700 Marcq-en-Barœul, France
  • Full-time
  • Contract type: Permanent Contract
  • Years of experience: 5 to 10 years
  • Activity: Human care

Company Description

Gnosis by Lesaffre, a business unit of Lesaffre, is a world expert in yeast, bacteria and pure molecules from fermentation, dedicated to human health and nutrition.

Founded in 1989 under the name of “Gnosis”, a technical term used throughout Greek philosophy to define “experience knowledge” in contrast to “theoretical knowledge”, Gnosis products are the result of long researches and tests.

The company aspires to be a trusted innovation partner for its clients in the pharmaceutical, nutritional and functional food industries.

Job Description

Within the Research & Applications Department of the Business Unit GNOSIS BY LESAFFRE, you will be Senior Regulatory Affairs Specialist :

  • as team member of the Regulatory Affairs and IP team you are responsible for proposing regulatory strategies for the innovation pipeline and for delivering regulatory compliance on every ingredients of the commercial range of Gnosis by Lesaffre;
  • the Regulatory Affairs & IP team is working very closely with the Market Managers, providing support to develop promotional materials and answer customers’ requests. A strong collaboration is in place with all other Research & Applications Departments, to complete market access and claims dossiers strategies for market access and claims dossiers.

Main missions : 

Your operational responsibilities in compliance will include :

  • participating to R&D projects as a key member for regulatory input;
  • proposing regulatory strategies and registering products from the product’s Gnosis range;
  • managing regulatory projects;
  • ensuring the regulatory watch;
  • participating to interprofessional syndicates. Some short travels in Europe will be planned;
  • communicating regulatory advices, timelines and regulatory status to other Gnosis departments and Lesaffre corporate teams when needed.

Furthermore, you will ensure a clear and regular reporting to the Regulatory Affairs & IP Team Leader.

Qualifications

With a high-level scientific background (MSc, PhD or Pharmacist) and at least 5 years’ experience in managing Regulatory Affairs in an international environment, you are ideally coming from a pharma or food company.

Your English is fluent.

Stable as well as open to change, you demonstrate abilities to drive projects. Customer-oriented, you undertake proactive actions, are prompt to propose solutions. Your regulatory expertise is recognized, and you are a good communicant, showing transparency and team-spirit.

Additional Information

All our positions are open to people with disabilities.

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