Iluma Alliance

Head of Global Regulatory Affairs

Iluma Alliance

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • Define and execute a 'US-Based but Global-Compliant' strategy.
  • Provide Master Dossiers to local distributors and agents.
  • Serve as the primary advocate and 'Subject Matter Expert' (SME) with the FDA, USDA, EFSA, UK FSA, and MARA.
  • Directly oversee and support the day-to-day preparation of technical dossiers.
  • Manage and protect the global patent portfolio.
  • Collaborate directly with Technical Directors to ensure R&D study protocols meet global regulatory standards.

Requirements

  • A PhD or MS in a biological discipline, Toxicology, Animal Health, Veterinary Medicine (DVM), Chemistry or Regulatory Affairs /Science.
  • A minimum of 15 years of progressive leadership in global regulatory affairs within the animal health or speciality chemical sectors.
  • Direct experience in feed additives would be an advantage.
  • Deep knowledge of FDA, USDA, and EFSA regulations, as well as intermediate knowledge of other global regulatory frameworks.
  • Experience in at least one or two major global regions (NA, EMEA, LATAM, or APAC).
  • Practical experience managing a global patent portfolio, including renewals and defensive strategies.
  • At least 5 years in a strategic leadership role with experience managing global teams and overseeing multi-million dollar regulatory projects.
  • Additional language skills would be an advantage.
Benefits
  • Medical dental, vision, and 401k.
  • Employee Assistance Program.
  • Hybrid working or WFH depending on proximity to Lawrenceville Office, GA.
  • A challenging position within a high-potential agri-tech company.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
PhDMSToxicologyAnimal HealthVeterinary MedicineChemistryRegulatory Affairsglobal patent portfolio managementfeed additivesR&D study protocols
Soft Skills
leadershipcollaborationadvocacystrategic planningteam management