Regulatory Specialist

Regulatory Specialist

We're seeking a Regulatory Specialist to support Regulatory Science and Regulatory Affairs activities across Elemental Enzymes' portfolio of biopesticides, biostimulants, and biofertilizers. The ideal candidate combines scientific curiosity, strong organizational skills, and the ability to work independently in a fast-paced environment. This role is well suited for an individual looking to develop broad expertise at the intersection of science, regulatory affairs, product development, and project execution.

The Regulatory Specialist reports to the Director of Regulatory and is part of the broader Regulatory Team.

• Coordinate assigned GLP and non-GLP studies with external laboratories and evaluate reports for scientific quality and alignment with regulatory requirements.
• Maintain scientific data, study records, and supporting documentation used for regulatory submissions.
• Assess product and study data to support regulatory decision-making.
• Support product stewardship activities, including GHS hazard classification and SDS development and review.

• Prepare components of regulatory submissions, reports, and related registration activities across global markets.
• Review labels, product specifications, and technical documentation for consistency, compliance, and regulatory impact, including support for formulation, manufacturing, and labeling change assessments.
• Maintain registration documentation to support ongoing compliance.
• Draft routine correspondence and support interactions with regulatory agencies, consultants, and business partners.

• Communicate project status, timelines, and potential risks to stakeholders.
• Support continuous improvement of processes, documentation, and systems.
• Assist with special projects and emerging business needs, as assigned.

• Bachelor’s degree in Biology, Chemistry, Agriculture, or related scientific discipline.
• 3-7 years of experience in agriculture or biotechnology, with exposure to regulatory affairs, laboratory operations, product development, technical services, or scientific project support preferred.
• Ability to learn and apply new scientific, technical, and regulatory concepts.
• Demonstrated ability to critically evaluate technical information and identify in consistences, gaps, or areas requiring additional investigation.
• Strong written and verbal communication skills and ability to prepare clear, organized technical documentation.
• High attention to detail and strong organizational skills.
• Ability to manage multiple priorities, adapt to changing business needs and timelines, and meet established deadlines.
• Ability to work independently following training and general direction.
• Demonstrated problem-solving skills and sound judgment.
• Proficiency with Microsoft Office Suite, particularly Excel, Word, and PowerPoint, and experience working within digital document management and collaboration platforms (e.g., Box, Dropbox, SharePoint). Experience using project management software such as Wrike is a plus.

• 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…