Regulatory Affairs Manager

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🔥 0 minutes ago

🗣️🇧🇷🇵🇹 Portuguese Required

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Logo of Elemental Enzymes

Elemental Enzymes

11 - 50 employees

Founded 2011

🍽️ Food & Beverage

🏭 Manufacturing

💼 Consulting

💰 Seed Round on 2013-04

Food & Beverage • Manufacturing • Consulting

Elemental Enzymes is a company dedicated to innovating within the agricultural sector by using nature's best solutions. They focus on developing sustainable agriculture technologies that enhance soil and plant health through enzyme, peptide, and biochemistry solutions, without altering the grower's existing practices. Their proprietary bio-amplifiers offer scalable and sustainable solutions for improving drought resistance, mitigating heat stress, and increasing fertilizer efficiency. By combining customer-centric focus and scientific expertise, they have partnered with major agricultural suppliers globally. The company works to support the agricultural community with novel technologies designed to address challenges such as nutrient availability, plant defenses, and disease resistance.

📋 Description

• Develop and execute regulatory strategies for testing, importation, and commercialization of products in Brazil • Lead regulatory submissions and manage approval processes with Brazilian authorities, including MAPA • Build and maintain project plans, timelines, and regulatory documentation • Interpret and submit agronomic data to support efficacy claims • Define allowable variations in product chemistry and other label parameters • Define required product composition and safety data • Ensure GHS hazard classification is updated with the relevant agency • Independently drive projects to completion while communicating status, risks, dependencies, and deadlines • Maintain existing registrations and complete agency reporting required for compliance • Collaborate with internal stakeholders, consultants, and business partners to align regulatory and commercial objectives • Communicate regulatory priorities, milestones, agency communications, and emerging risks • Serve as primary liaison with regulatory agencies and consultants • Monitor regulatory changes and assess impacts on current and future registrations • Provide strategic foresight for LATAM expansion and long-term regulatory planning

🎯 Requirements

• Bachelor’s or Master’s degree in Biological Sciences or related field • Fluency in Portuguese and English • Spanish proficiency is a plus • Demonstrated experience with Brazilian regulatory frameworks for biopesticides, bio-inputs, and fertilizers • Exceptional written and verbal communication skills • Experience interacting with regulators and managing external consultants • Ability to work independently in a remote or distributed work environment • Ability to identify priorities, drive execution, and follow through on commitments • High attention to detail and commitment to regulatory compliance • Ability to maintain accurate and complete regulatory documentation • Strategic problem-solving ability • Strong negotiation and relationship-building skills • Experience managing multiple complex projects and timelines while meeting deadlines • Ability to travel up to 40%

🏖️ Benefits

• Benefits in accordance with Brazilian employment laws • Remote or distributed work environment • Salary based on qualifications and experience

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