Head of Regulatory Affairs (Biologicals)

Title: Head of Regulatory Affairs (Biologicals)

Function: Global Market Access & Regulatory Affairs

Reports to: Chief Marketing Officer

Location: UK / Europe

About Azotic Technologies

Azotic Technologies is an innovative agricultural biotechnology scale-up transforming how crops access nitrogen. We develop and commercialise biological solutions that help farmers improve yields while reducing reliance on synthetic fertilisers. Built on world-leading science, our technology is already operating in global agricultural markets, with strong commercial momentum across major crop systems. As demand for sustainable, high-performance crop inputs accelerates, Azotic is positioned in an exciting high-growth sector.

Role Purpose

We are seeking an experienced Head of Regulatory Affairs to build and lead a critical business function responsible for ensuring Azotic can legally register, import, export, distribute, and sell products in target markets worldwide. This is an important operational leadership role focused on accelerating international growth by removing regulatory and market access barriers.

You will develop global market access strategies, manager regulatory and registration requirments, establish trade compliance processes, manage external regulatory & trade partners, and build a scalable function capable of supporting Azotic's expansion across new markets specifically LATAM, Africa, and APAC. The role will lead and develop the function - implementing the structure, systems, and governance required for a high-growth international business.

Success metrics will include areas such as, time-to-registration, number of new markets opened, dossiers approved first time, zero critical compliance incidents.

Key Responsibilities

Market Access & Global Expansion

• Work with CMO to implement Azotic's global market access strategy to support international growth objectives
• Assess market entry based on regulatory complexity, timelines and cost
• Identify regulatory, trade, customs, and operational barriers to market entry and develop mitigation plans
• Provide strategic updates to senior leadership on market access risks and opportunities
• Establish regulatory intelligence processes to monitor changes in legislation and market requirements globally

Regulatory Affairs Leadership and Budget Ownership

• Oversee and manage a small regulatory team and its activities across markets
• Develop country-specific registration strategies and approval pathways
• Oversee dossier development, submission, approvals, renewals, amendments, and maintenance activities
• Manage interactions with regulatory authorities and government agencies globally
• Ensure compliance with all relevant regulations governing product registrations, claims and labelling,
• Drive continuous improvement of regulatory processes, systems, and documentation
• Prepare and own the functional budget
• Trade Compliance & Product Movement
• Establish and manage global import/export compliance processes
• Ensure all products can be legally moved into target markets in accordance with local regulations
• Develop and maintain trade compliance frameworks covering permits, licences, customs requirements, and product classifications
• Oversee HS code strategy and customs classification activities
• Ensure compliance with biosafety, product movement, and trade regulations
• Partner with operations and supply chain teams to minimise delays and compliance risks

Trade Compliance & Product Movement

• Establish and manage global import/export compliance processes
• Ensure all products can be legally moved into target markets in accordance with local regulations
• Develop and maintain trade compliance frameworks covering permits, licences, customs requirements, and product classifications
• Oversee HS code strategy and customs classification activities
• Ensure compliance with biosafety, product movement, and trade regulations
• Partner with operations and supply chain teams to minimise delays and compliance risks

Leadership, Stakeholder & Partner Management

• Lead, develop, and strengthen the Market Access & Regulatory Affairs function to support global growth
• Establish clear objectives, accountability, performance standards, and scalable processes across the team
• Identify capability gaps and build the resources, systems, and governance required to support future expansion
• Build and manage a global network of regulatory consultants, legal advisors, customs brokers, local agents, and specialist service providers
• Select, negotiate, and manage third-party partners to ensure high-quality support and value for money
• Coordinate resources to accelerate registrations, approvals, and market access activities
• Develop strong relationships with regulatory authorities, industry associations, and key stakeholders
• Work closely with Commercial, Marketing, Technical, Operations, Supply Chain, Legal, and Finance teams

Skills & Experience

• Minimum 8 years experience in Market Access, Regulatory Affairs, Trade Compliance within agriculture, biotechnology, biologicals, crop protection, seed.
• Proven experience leading international market access and regulatory activities across multiple countries for agri input biologicals.
• Strong understanding of product registration, regulatory approval pathways, and market entry requirements
• Demonstrated success delivering product registrations and enabling commercial access in international markets
• Experience managing import/export compliance, customs requirements, permits, and trade regulations
• Experience working with external consultants, regulatory agencies, customs brokers, and other specialist providers
• Experience within agricultural biologicals, crop protection, seed, microbial technologies, or related sectors preferred
• Experience working within biotech regulatory role in one or more of the following regions: LATAM, Africa, APAC
• Knowledge of biosafety, biological product regulations, and international regulatory frameworks
• Strong leadership skills with the ability to build teams, improve performance, and drive accountability
• Commercially minded with a clear understanding of how market access supports business growth
• Strategic thinker who can balance long-term planning with hands-on delivery
• Strong project management and organisational skills, with the ability to manage multiple priorities across international markets
• Excellent communication and stakeholder management skills, with the ability to influence internal and external partners
• Proactive problem solver with a practical, solutions-focused approach
• Resilient, adaptable, and comfortable operating in a fast-paced scale-up environment

What We Offer

• Salary depending on experience
• Remote / Hybrid / Flexible working
• 28 days holiday
• Private medical
• Pension
• Supportive, growth-focused commercial environment
• Company bonus scheme

Interested candiates to please send CV with short cover note to