Regulatory Specialist

Regulatory Specialist

Job Description

Were 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

• Bachelors 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:

• 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.

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 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.

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. Thats 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.

To apply complete the job application on our website and submit your resume and cover letter.

Required Experience:

Senior IC