Regulatory Specialist
elementalenzymes · Saint Louis
Job description
About the role
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.
Key responsibilities
- Coordinate assigned GLP and non‑GLP studies with external laboratories and evaluate reports for scientific quality and regulatory alignment.
- Maintain scientific data, study records, and supporting documentation used for regulatory submissions.
- Assess product and study data to support regulatory decision‑making and product stewardship activities, including GHS hazard classification and SDS development.
- Prepare components of regulatory submissions, reports, and registration activities across global markets.
- Review labels, product specifications, and technical documentation for consistency, compliance, and regulatory impact.
- Maintain registration documentation to support ongoing compliance and draft routine correspondence with regulatory agencies, consultants, and business partners.
- Communicate project status, timelines, and potential risks to stakeholders and support continuous improvement of processes, documentation, and systems.
- Assist with special projects and emerging business needs as assigned.
Required profile
- 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, or scientific project support.
- Ability to learn and apply new scientific, technical, and regulatory concepts.
- Strong written and verbal communication skills and ability to prepare clear, organized technical documentation.
- High attention to detail, strong organizational skills, and ability to manage multiple priorities.
- Demonstrated problem‑solving skills, sound judgment, and ability to work independently.
- Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and experience with digital document‑management platforms (Box, Dropbox, SharePoint); experience with project‑management software such as Wrike is a plus.
Required skills
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Box
- Dropbox
- SharePoint
- Wrike (optional)
What we offer
- Competitive base salary
- 401K with match
- Comprehensive health, dental, vision, and life insurance
- HSA/FSA options and long‑term incentive plan
- Employee assistance, disability, pet, accident, critical illness, and hospital indemnity insurance
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Published 2 hours ago
Expires 1 month from now
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elementalenzymes
Saint Louis
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