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PhycoTerra® · 16 hours ago

Regulatory Affairs Associate

Gilbert, AZ

Full-time

Onsite

Entry Level

1+ years exp

Heliae is a leading ag tech company focused on sustainable practices and microbial-based products. The Regulatory Affairs Associate will support the registration and compliance of bio-based products, ensuring adherence to relevant regulations and streamlining submission processes.

BiotechnologyHealth CareNutritionTherapeutics

Responsibilities

Prepare, review, and submit regulatory dossiers for products in compliance with national and international regulations

Maintain up-to-date knowledge of regulations applicable to biostimulants, including EPA, USDA, state-level compliance, and OMRI organic standards

Support R&D, Product Development, Manufacturing, and Quality teams to ensure regulatory compliance during product development and commercialization

Assist in the preparation and maintenance of regulatory documentation, including Safety Data Sheets (SDS), product labels, technical files, and registration reports

Coordinate with external consultants, testing labs, and regulatory agencies for submissions, amendments, or inquiries

Track submission timelines, renewal dates, and compliance deadlines to ensure timely approvals and ongoing compliance

Support audits, inspections, and reporting requirements as needed

Contribute to improving regulatory processes and maintaining regulatory knowledge management

Other administrative duties as required

Qualification

Regulatory affairs experienceTechnical writingBiology degreeMicrobial biostimulant registrationsInternational regulationsInterpersonal skillsOrganizational skillsProject management