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Regulatory Affairs and R&D Specialist

Il y a 2 mois

Paris, Île-de-France Lallemand Temps plein

Lallemand Animal Nutrition (LAN) is seeking a dynamic and experienced individual for the role of Regulatory Affairs and R&D Liaison Manager.

This pivotal role will bridge between our Research & Development and Business Access teams, combining scientific expertise with regulatory acumen to ensure compliance, streamline communication, and successfully drive market access projects. The candidate will be working on projects related to market access in key jurisdictions such as the EU, US, and Canada.

Key Responsibilities:

  • Collaboration and Project Management:
    • Serve as the primary liaison to ensure clear communication channels between R&D and Business Access teams, ensuring alignment on goals, timelines, and requirements.
    • Be involved in early R&D project discussions for alignment on project goals versus business needs and regulatory strategy and requirements.
    • Coordinate project plans between R&D, Business Access, and other relevant departments (e.g., marketing), monitor progress.
    • Prioritize tasks based on regulatory deadlines and business objectives.
  • Regulatory Strategy, Compliance and Scientific Expertise:
    • Stay informed about evolving regulatory and technical requirements for regulated products in key jurisdictions (e.g., EU, US, Canada).
    • Interpret and apply regulatory guidelines and technical guidance to ongoing R&D projects.
    • Explore opportunities for proactive engagement with regulatory bodies (notably via involvement in industry associations).
    • Ensure a robust strategy for regulatory submissions, considering safety, efficacy, and product identity.
  • Analytical Skills and Attention to Detail:
    • Review and analyze study protocols linked to regulatory submissions (and identify potential gaps or inconsistencies versus regulatory requirements), scientific literature and reports, and regulatory documents.
    • Understand the scientific principles behind product development, formulation, efficacy and safety.
    • Evaluate regulatory risks and benefits by evaluating different approaches thoroughly.
    • Ensure accuracy in all regulatory documentation.
  • Self-Motivation, Independence, and Team Collaboration:
    • Work autonomously on assigned projects.
    • Take initiative to address challenges and seek solutions.
    • Demonstrate a proactive attitude toward continuous learning.
    • Encourage cross-functional collaboration beyond R&D, including quality, legal, and marketing.