Regulatory Specialist
Elemental Enzymes
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.
Responsibilities
Regulatory Science Support
- 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.
Regulatory Affairs Support
- 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.
General Support
- 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.
Qualifications
- 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 inconsistences, 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.
Physical Demands
- Extend self in a direction to complete a
- Remaining in one position for sustained periods of
- Moving to accomplish tasks, particularly for long distances or moving from one work site to
- Using fingers for tasks such as typing, picking, or pinching, rather than full hand
- Moving objects from a lower to a higher position or moving objects horizontally from position-to-
- Gripping, grasping, or applying pressure to objects using fingers and
- Using tools and equipment including a work computer and other office devices such as printers, calculators, etc.
- Engaging in recurring movements of the wrists, hands, or fingers, such as typing or assembling components.
Physical Requirements
- Assessing the size, shape, texture, or temperature of objects by touch, particularly with
- Expressing or exchanging ideas by spoken word, including providing detailed or critical instructions clearly, quickly, and
- The worker is not substantially exposed to adverse environmental conditions and operates primarily in an indoor setting.
Job Location: St. Louis, MO, United States
Position Type: Full-Time/Regular/Salary/Exempt
Salary: Competitive base range
Benefits: 401K with match, Healthcare, Dental, Vision, Life Insurance, HSA/FSA options, Long-term incentive plan, Dependent Care Account, Employee Assistance Program, Short-Term Disability, Long-Term Disability, Pet Insurance, Accident Insurance, Critical Illness Insurance, Hospital Indemnity Insurance
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.
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