Regulatory Affairs Manager - LATAM

elementalenzymes; São Paulo; Presencial; BRL 180 000 - 320 000; Tempo integral

Resumo da oferta

Elemental Enzymes seeks a Regulatory Affairs Manager – LATAM to lead regulatory strategies across Brazil and support broader LATAM initiatives. This role requires proactive thinking, collaboration with internal teams, and effective liaison with regulators.

You will build filing plans, manage submissions with MAPA, ensure compliant labeling and data requirements, and drive registrations while coordinating with consultants and partners.

Qualificações

• 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, with demonstrated success interacting with regulators, managing external consultants, and providing clear, concise updates to stakeholders across functions.
• Demonstrated ability to work independently in a remote or distributed work environment, identify priorities, drive execution, and follow through on commitments.
• High attention to detail and ability to maintain accurate regulatory documentation.

Responsabilidades

• Develop and execute regulatory strategies for testing, importation, and commercialization of products in Brazil.
• Lead regulatory submissions and manage approval processes with Brazilian authorities (e.g., MAPA).
• Build and maintain project plans, timelines, and documentation for regulatory activities.
• Interpret agronomic data to support efficacy claims.
• Define needed data on product composition and safety.
• Ensure GHS hazard classification is updated for the relevant agency.
• Independently drive projects to completion with minimal supervision and keep stakeholders informed of status and deadlines.
• Maintain existing registrations and complete all agency reporting required for compliance.
• Collaborate with internal stakeholders, consultants, and partners to align regulatory goals with commercial objectives.
• Establish regular communication with internal stakeholders regarding regulatory priorities and milestones.

Conhecimentos

Regulatory strategy

Communication skills

Remote work capability

Project management

Attention to detail

Formação académica

Biological Sciences degree

Descrição da oferta de emprego

Regulatory Affairs Manager – LATAM

The Regulatory Affairs Manager – LATAM will serve as a strategic individual contributor responsible for leading regulatory efforts across Brazil and supporting broader LATAM initiatives. This role requires a proactive, forward-thinking approach to regulatory strategy, with the ability to anticipate market trends, navigate complex regulatory landscapes, and influence long-term business success.

Reporting to the Director of Regulatory (U.S.-based), the manager will collaborate with internal teams, external consultants, and government agencies to ensure compliance and enable market access for Elemental Enzymes’ portfolio of biopesticides, biostimulants, and biofertilizers.

Responsibilities

• Develop and execute regulatory strategies for testing, importation, and commercialization of products in Brazil.
• Lead regulatory submissions and manage approval processes with Brazilian authorities (e.g., MAPA).
• Build and maintain project plans, timelines, and documentation for regulatory activities.
  • Interpret and submit agronomic data to support efficacy claims.
  • Interpret allowable variations in product chemistry and other parameters for labels
  • Define needed data on product composition and safety.
  • Ensure GHS hazard classification is updated for the relevant agency.
• Independently drive projects to completion with minimal supervision, ensuring stakeholders are informed of status, risks, dependencies, and upcoming deadlines.
• Maintain existing registrations and complete all agency reporting required for compliance.
• Collaborate with internal stakeholders, consultants, and business partners to align regulatory goals with commercial objectives.
• Establish and maintain regular communication with internal stakeholders regarding regulatory priorities, project milestones, agency communications, and emerging risks.
• Serve as the primary liaison with regulatory agencies and consultants, connecting regulatory frameworks with emerging technology.
• Monitor regulatory changes and assess their impact on current and future product registrations.
• Provide strategic foresight to support LATAM expansion and long-term regulatory planning.

Qualifications

• 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, with demonstrated success interacting with regulators, managing external consultants, and providing clear, concise, and proactive updates to stakeholders across multiple functions and geographic locations.
• Demonstrated ability to work independently in a remote or distributed work environment, identify priorities, drive execution, and follow through on commitments while maintaining high levels of accountability, responsiveness, and professional reliability.
• High attention to detail, commitment to regulatory compliance, and ability to maintain accurate and complete regulatory documentation.
• Strategic mindset with the ability to solve problems collaboratively.
• Strong negotiation and relationship-building skills.
• Experience managing multiple complex projects and timelines while consistently meeting established deadlines.

Physical Demands

• Extending: Extend self in a direction to complete a task.
• Stationary Position: Remaining in one position for sustained periods of time.
• Moving: Moving to accomplish tasks, particularly for long distances or moving from one work site to another.
• Fine Motor Skills: Using fingers for tasks such as typing, picking, or pinching, rather than full hand movements.
• Transporting: Moving objects from a lower to a higher position or moving objects horizontally from position-to-position.
• Manual Handling: Gripping, grasping, or applying pressure to objects using fingers and palms.
• Operating: Using tools and equipment including a work computer and other office devices such as printers, calculators, etc.
• Repetitive motion: Engaging in recurring movements of the wrists, hands, or fingers, such as typing or assembling components.

• Sensory Touch: Assessing the size, shape, texture, or temperature of objects by touch, particularly with fingertips.
• Communicating: Expressing or exchanging ideas by spoken word, including providing detailed or critical instructions clearly, quickly, and accurately. Perceiving sound details at normal speaking levels. Alternative methods of communication can be utilized as necessary.
• Environmental Exposure: The worker is not substantially exposed to adverse environmental conditions and operates primarily in an indoor setting.

Physical Requirements

• Sensory Touch: Assessing the size, shape, texture, or temperature of objects by touch, particularly with fingertips.
• Communicating: Expressing or exchanging ideas by spoken word, including providing detailed or critical instructions clearly, quickly, and accurately. Perceiving sound details at normal speaking levels. Alternative methods of communication can be utilized as necessary.
• Environmental Exposure: The worker is not substantially exposed to adverse environmental conditions and operates primarily in an indoor setting.

Location: Brazil (with travel to MAPA as needed)

Position Type: Full-Time / Regular / Salary / Exempt

Travel Requirement: Up to 40%

Salary: Competitive, based on qualifications and experience

Benefits: In accordance with Brazilian employment laws

About Elemental Enzymes

Elemental Enzymes was founded upon the simple belief that we must do everything we can to improve agricultural performance in a way that not only enables plants to flourish but enriches and renews the planet with eco-friendly and sustainable agricultural solutions. From products that enable effective enzyme, peptide and biochemistry-driven inputs to foliar treatments that hold the promise to renew entire industries, our focus to make a positive difference in the world through people – like you and me. Success is a byproduct of responsible production. That’s why Elemental Enzymes works to bring cross-disciplinary scientists and processes together to create novel solutions to practical problems with a shared goal of helping both the plant and the planet.