Senior Regional Regulatory Affairs Specialist - LATAM

Senior Regional Regulatory Affairs Specialist - LATAM

Industry: Biotechnology
Location: Oxford, Abingdon, or Remote
Contract Type: Permanent

About The Company

The organization focuses on innovative biological solutions for pest control, aimed at preventing diseases and reducing agricultural damage. Founded in 2002, they prioritize environmentally sustainable practices, including genetic modification of pests for biological control without chemicals.

Their technology involves engineering insects with self-limiting genes to reduce pest populations. The company focuses on controlling pests that transmit diseases such as malaria, dengue, and Zika, and crop-damaging insects. They also aim to contribute to sustainable farming practices and food security goals globally.

Focus of the Role

The Senior Regional Regulatory Affairs Specialist will manage regulatory strategies to ensure product approvals and registrations across Latin America (LATAM). The role requires advanced knowledge in biological products, genetically modified organisms (GMOs), and technologies like Wolbachia-based vector control. The Specialist will navigate complex regulatory requirements, ensuring compliance with biosafety, risk assessments, and environmental release protocols. This involves close collaboration with internal R&D teams and external regulatory bodies.

Key Responsibilities

Strategic Regulatory Leadership

• Develop regulatory strategies for product registrations and life cycle approvals in LATAM.
• Monitor and communicate regulatory changes in LATAM and assess their impact on the product portfolio.
• Provide regulatory advice to internal stakeholders during product development, launch, and post-approval.
• Report regulatory risks and strategies to the Head of Department.
• Identify opportunities for regulatory process improvements.

Regulatory Submissions and Compliance

• Lead regulatory dossier preparations for new products, renewals, and variations across LATAM.
• Manage post-market activities, including adverse event reporting and compliance audits.
• Respond to regulatory authority queries and facilitate timely submissions.
• Ensure compliance with international, regional, and country-specific regulations.
• Review labeling, packaging, and promotional materials for compliance.
• Guide environmental, social, and economic impact studies to ensure compliance with government regulations.

Cross-Functional Collaboration

• Work with R&D, commercial teams, and external partners to align regulatory efforts with business goals.
• Maintain relationships with external partners and consultants to streamline processes.
• Represent the company in meetings with regulatory agencies and industry associations.
• Support local teams in maintaining compliance during field trials and commercialization.

Regulatory Documentation and Reporting

• Keep accurate records of regulatory submissions, approvals, and correspondence.
• Prepare and submit applications for product approvals, licenses, and permits.
• Provide updates on regulatory statuses to internal stakeholders.
• Ensure agreed KPIs are met within specified timelines.

Audit and Inspection Support

• Assist in preparing for regulatory inspections and audits.
• Support the implementation of corrective actions for audit findings.

Role Requirements

Essential

• A BSc in biological or life sciences, regulatory affairs, entomology, or similar.
• 5+ years' experience in regulatory affairs, with expertise in LATAM regions.
• Experience handling regulatory submissions and approvals in LATAM markets.
• In-depth knowledge of GMO regulations, biological insect control, and life cycle management in LATAM.
• Proven success in achieving regulatory approvals and interacting with agencies.
• Familiarity with international regulatory guidelines.
• Excellent project management and organizational skills.
• Proficient in English, with additional LATAM languages a plus.
• Strong analytical and problem-solving skills, with the ability to manage multiple projects.
• Proficiency in Microsoft Office, Teams, SharePoint, and regulatory systems.
• Willingness to travel within LATAM and to the company's head office as needed.

Behavioral Requirements

• Passionate about the organization's mission.
• Adaptable to work across different time zones and cultures.
• Collaborative, professional, and solutions-oriented.
• Ability to work under pressure and manage urgent tasks efficiently.

Salary & Benefits

£60,000 - £85,000 per annum (depending on experience)

• Tiered pension scheme
• Bonus scheme
• Life assurance
• Lifestyle coaching
• 24hr GP
• Mental health support
• Eye tests

and much more, please ask for the full benefits package.

If interested, please send your CV to (see below)