Product Regulatory Analyst

Posted 4 Days Ago
Be an Early Applicant
Lakewood, CO, USA
Hybrid
95K-105K Annually
Senior level
Biotech • Agriculture • Chemical • Manufacturing
The Role
Manages domestic and international product registrations, renewals, amendments, compliance documentation, labeling, market-entry assessments, and regulatory relationships. Advises Portfolio, Commercial, R&D, and Supply Chain teams on regulatory requirements, claims, timelines, costs, and market feasibility. Maintains registration records, compliance calendars, labels, and market knowledge resources while contributing to new product development and registration budgeting.
Summary Generated by Built In

Product Regulatory Analyst

About Us …

A leader in the Biostimulant industry, Horizon Ag Products began manufacturing soluble humus products for Agriculture in 1983.  Based in Lakewood, CO, we are a recognized leader in our industry. With approximately 120 employees, we operate six manufacturing plants in six states and several surface mines.  We strongly believe our products are of significant benefit to mankind, and we make them better than anyone else in the world.  We support a lifestyle of balanced priorities where everyone works hard and enjoys themselves and each other.  We look out for one another and cherish the caring attitude and respect we have for one another in the workplace and beyond.  Above all else, we conduct ourselves with integrity and follow the guiding principles outlined on our website, www.horizonag.com.

Summary:

The Product Regulatory Analyst is a member of the company's Regulatory and Sustainability team. This position acts as the subject-matter expert on product compliance and registration activities in both current and future markets. The role owns domestic registrations and renewals and leads international registration and market access, working directly with in-country registrants, distributors, and regulatory authorities.

This team member is the first point of contact for the Portfolio, Commercial, and R&D teams before they commit to a market, a claim, or a new formulation. The role is hands-on, highly autonomous, and best suited for an individual who has already prepared and managed these filings independently. Our environment is highly collaborative, and we strive to continually innovate. The successful candidate will also demonstrate a strong work ethic and dedication to company goals, as well as a commitment to learning, strong problem-solving skills, clear and effective cross-departmental communication, and meticulous attention to detail.

Essential Duties & Responsibilities:

• Managing domestic and international registrations in current and future markets - identifying the appropriate pathway and assembling dossiers through submitting registrations, renewals, and amendments, and maintaining compliance items such as tonnage reports and certifications

• Researching and scoping new markets ahead of commercial commitment, including registration, testing, and claim requirements, timelines, and costs, coordinating with local partners or customers as appropriate.

• Managing relationships with regulatory agencies, in-country registrants, agents, and consultants.

• Providing cross-departmental guidance on labeling requirements and reviewing for compliance[MS1] [MS2]

• Maintaining the label repository on SharePoint, logging labels and making edits upon review or request.

• Monitoring regulatory developments and advising Portfolio, Commercial, R&D, and Supply Chain on registration feasibility, timelines, and costs, and responding to customer regulatory documentation requests.

• Maintaining compliance calendars, registration records, and a shared market-entry knowledge base.

• Representing Horizon with industry associations as appropriate.

• Building the registration plan and the related budget, and monitoring both together with the Portfolio and Commercial teams.

• Participating actively in new product development as a core member of project teams, defining regulatory requirements, timelines, and costs from concept to launch.

Education & Experience:

In addition to the qualities and skills described above, this team member should possess as many of the following qualifications as possible:

• Bachelor's degree in Agronomy, Soil Science, Chemistry, Biology, Agricultural Science, Environmental Science, Regulatory Affairs, or a closely related field - required

• 5 years’ experience in the biostimulant or crop-input industry in a regulatory or compliance role, including at least 2 years with direct ownership of international registrations - required[MS3] [MS4]

• Strong organizational, interpersonal, and communication skills - required

• Registration experience in one or more priority markets (LATAM, APAC, EMEA) – [MS5] required

• Experience with humic substances[MS6] - preferred

• Working proficiency in Spanish – preferred

Additional Information:

Classification: Paid bi-weekly, benefits eligible

Reports to: Manager of Regulatory and Sustainability

Job Location: Lakewood, CO (hybrid)

Travel: 10-15% (domestic, occasional international)

Horizon Ag-Products is an Equal Opportunity Employer.

Horizon Ag-Products will not sponsor applicants for work visas for this position.

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Skills Required

  • Bachelor's degree in Agronomy, Soil Science, Chemistry, Biology, Agricultural Science, Environmental Science, Regulatory Affairs, or a closely related field
  • Five years of experience in the biostimulant or crop-input industry in a regulatory or compliance role
  • At least two years of direct ownership of international registrations
  • Strong organizational, interpersonal, and communication skills
  • Registration experience in one or more priority markets: LATAM, APAC, or EMEA
  • Experience with humic substances
  • Working proficiency in Spanish
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The Company
HQ: Louisville, CO
84 Employees
Year Founded: 1983

What We Do

Horizon Ag-Products, LLC is a science and research-driven producer of innovative, naturally-derived plant health solutions for the global agricultural market. The company specializes in increasing nutrient uptake efficiency to improve fertilizer performance and maximize crop quality and yields. Its mission is to enable sustainable farming and environmental stewardship worldwide by providing scientifically-proven, naturally-derived products.

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