Head of Global Regulatory Affairs

Iluma Alliance

1d•Hybrid

About The Position

Anitox partners with the world’s leading feed ingredient, poultry, swine and farmed fish producers, enabling them to make safer food more efficiently through the development of clean feed technologies. Today our class leading portfolio is set to grow following acquisition by Iluma Alliance in 2024. We’re focused on innovative chemical and biological solutions to improve livestock performance, control Salmonella, E.coli, Clostridia and a host of viruses which impact animal welfare, productivity and human food security, and drive milling efficiency. We are currently seeking a Head of Global Regulatory Affairs to serve as the ultimate global authority for Anitox on all regulatory, patent, and biosecurity matters. This role defines the strategic vision to secure and maintain market access in 60+ countries, ensuring Anitox remains the "gold standard" in pathogen control through rigorous scientific advocacy and patent protection. This is a hands-on leadership role responsible for navigating complex global product registrations, protecting intellectual property, and ensuring seamless market access through direct management of dossiers and authority relationships. The ideal candidate will be a senior-level regulatory professional with a proven track record of strategic leadership within a multinational context, with expertise in animal health / feed additives or speciality chemical sectors. If this sounds like you, then this could be your perfect next career move...

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.

Nice To Haves

Additional language skills would be an advantage.

Responsibilities

Global Regulatory Strategy & EU-Compliance
Strategic Decisioning: Define and execute a "US-Based but Global-Compliant" strategy, ensuring all global dossiers meet the highest data standards to allow for seamless downstream leverage in LATAM, USA, EMEA, and APAC.
Market Access & Distributor management: Provide Master Dossiers to be leveraged by local distributors and agents to maximize speed-to-revenue while maintaining central control. Determine the optimal regulatory pathways (GRAS, Feed Additive Petition, etc.) for new products across Poultry, Swine, and Aquaculture sectors.
Agency Liaison: Serve as the primary advocate and "Subject Matter Expert" (SME) with the FDA, USDA, EFSA, UK FSA, and MARA.
Hands-On Global Registration & Execution
Dossier Authorship: Directly oversee and support the day-to-day preparation of technical dossiers for the FDA, EFSA, UK FSA, and MARA.
Succession Stewardship: Actively manage and document regional registration workflows currently held by senior staff and consultants to mitigate "key person" risks.
Problem Solving: Resolve daily operational roadblocks in product registrations, using deep technical knowledge to "unstick" submissions with health authorities.
Intellectual Property (IP) & Global Patent Management
Patent Stewardship: Manage and protect the global patent portfolio; lead the renewal, defence, and strategic challenge of patents for our core technologies and products.
Innovation Strategy: Provide jurisdictional advice on new patent filings and strategies to protect proprietary pathogen-control technologies, identify new patent opportunities during the R&D phase and secure Anitox’s long-term competitive advantage in the feed security sector.
Product Development, Technical Support and Sales Enablement
Product Development Support: Collaborate directly with Technical Directors to ensure R&D study protocols meet global regulatory standards for efficacy and safety, as well as integrate regulatory "Decision Gates" into the R&D process, preventing delays in product commercialization.
Claims Approval: Final authority on global marketing claims, ensuring every performance and pathogen-control claim is scientifically substantiated and legally defensible/compliant in all jurisdictions.
Safety, Science & EHS Advisory
EHS Advisory: Supply senior technical advice for Health & Safety; oversee global Safety Data Sheet (SDS) compliance and perform emissions/safety calculations for customer sites. Supply critical safety data for transport permits, storage, and emissions calculations and labelling compliance globally.
Proactive Intelligence: Monitor global megatrends (e.g., ASF virus, sustainability shifts) to advise the board on long-term portfolio risks and opportunities.
Biosecurity Evidencing: Assist customers in providing regulatory evidence for their own biosecurity and quality standards.
Problem Solving & Anticipatory Leadership:
Demonstrate an "expert-level" ability to solve complex scientific and regulatory problems independently, often under tight commercial deadlines.
Navigate highly complex, often conflicting international mandates. Requires the ability to anticipate and pivot strategies (e.g., US-first vs. EFSA-first) based on shifting geopolitical or regulatory landscapes, or finding "Go/No-Go" pathways for novel ingredients.
Predict future global challenges such as the increasing scrutiny of formaldehyde, emerging viruses like ASFV, sustainability shifts, microbial resistance - and provide sustainable business solutions that balance compliance with commercial viability.
People Management
Leadership: Recruit, mentor, and upscale the global regulatory team, fostering a solution-oriented culture.