
Head of Global Regulatory Affairs
Iluma Alliance
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
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