Regulatory Affairs Associate - Ag Biologicals and Microbial Products

Our client, an Ontario-based biotech startup focusing on advancing sustainable agriculture and farming practices,

is seeking a Regulatory Affairs Associate with 1-2 years of regulatory experience and an educational background in Microbiology, Biotechnology, Biology, Medical Sciences, or a related discipline.

The successful candidate will support the registration, approval, renewal, and ongoing compliance of our microbial and biological products across multiple international markets. This role will involve coordinating with regulatory authorities, external consultants, laboratories, manufacturing teams, and internal scientific and commercial teams.

This is an ideal opportunity for an early-career regulatory professional interested in agricultural biologicals, microbial products, biostimulants, biofertilizers, soil amendments, and biocontrol products.

This is an associate-level position and is not intended to be a senior regulatory leadership role. The successful candidate should have enough experience to independently coordinate submissions and compliance activities while working under the guidance of company leadership, scientific teams, and external regulatory consultants.

Employment Type: Permanent Full-Time

Location: London, Ontario (onsite)

What You'll Do  

Product Registrations and Regulatory Projects

• Manage regulatory projects for new product registrations across the United States, Canada, Europe, the United Kingdom, and other international markets.
  
• Coordinate directly with federal, state, provincial, and international regulatory authorities.
  
• Prepare and submit applications for new product registrations, amendments, renewals, and annual regulatory reporting.
  
• Track application timelines, regulatory queries, renewal dates, reporting obligations, and registration status.
  
• Follow up with regulatory authorities and respond to requests for additional information.
  

Technical Dossier Preparation

• Prepare technical dossiers and supporting documentation for new product submissions.
  
• Compile product composition, manufacturing information, specifications, certificates of analysis, safety data sheets, labels, efficacy information, stability data, microbial identification records, and supporting scientific literature.
  
• Review technical documents for accuracy, consistency, and regulatory compliance.
  
• Coordinate with scientific and production teams to obtain required technical information.
  
• Maintain organized and confidential regulatory records for each product and jurisdiction.
  

Regulatory Pathway Assessment

• Work with regulatory consultants to identify suitable regulatory pathways for launching agricultural products in new markets.
  
• Research product classifications and registration requirements for microbial products, biofertilizers, biostimulants, soil amendments, and biological control products.
  
• Assist in identifying regulatory data gaps and developing plans to generate the required studies, testing, or documentation.
  
• Monitor changes in applicable regulations, guidance documents, labelling requirements, and reporting obligations.
  

Product Compliance and Renewals

• Support ongoing compliance of registered products, labels, claims, packaging, and technical documentation.
  
• Manage state-level registrations, renewals, tonnage reporting, sales reporting, and other recurring compliance requirements.
  
• Maintain a regulatory calendar covering renewal deadlines, annual reports, fees, and submission dates.
  
• Review proposed product labels, claims, marketing materials, and technical documents from a regulatory perspective.
  
• Assist with regulatory compliance checks before products are launched in new territories.
  

Internal and External Coordination

• Coordinate with external regulatory consultants, accredited laboratories, distributors, customers, and government authorities.
  
• Work closely with microbiology, quality, manufacturing, sales, and product-development teams.
  
• Provide regular project updates and highlight regulatory risks, delays, information gaps, and upcoming deadlines.
  
• Support customer regulatory questionnaires and requests for product documentation.
  
• Participate in meetings with consultants, customers, and regulatory authorities when required.
  

Requirements

• Bachelor’s degree in Microbiology, Biotechnology, Biology, Agricultural Science, Life Sciences, or a related field.
  
• Approximately 1–2 years of experience in regulatory affairs, product registrations, quality compliance, or a related technical role.
  
• Experience with agricultural inputs, biological products, fertilizers, biostimulants, pesticides, microbial products, food, feed, or life-science products is preferred.
  
• Familiarity with regulatory submissions, technical dossiers, product labels, safety data sheets, and certificates of analysis.
  
• Strong technical writing, documentation, research, and organizational skills.
  
• Ability to manage multiple projects, jurisdictions, and deadlines simultaneously.
  
• Strong attention to detail and ability to handle confidential technical information.
  
• Clear written and verbal communication skills.
  
• Proficiency with Microsoft Word, Excel, document-management systems, and online regulatory portals.
  
• Experience in one or more of the following areas would be highly preferred:
  

- U.S. state fertilizer, soil amendment, or microbial product registrations.
- Canadian fertilizer, supplement, pesticide, or biological-product regulations.
- European Union or United Kingdom agricultural-input regulations.
- Microbial identification, strain documentation, fermentation, formulation, or quality-control processes.
- Organic-input approvals or certifications.
- Label review and claims compliance.
- Working with regulatory consultants, laboratories, or government agencies.

Key Competencies:

• Strong project coordination and follow-up.
  
• Scientific and regulatory research capabilities.
  
• Technical document preparation.
  
• Attention to detail.
  
• Deadline and compliance management.
  
• Professional communication with regulatory authorities.
  
• Ability to interpret regulations and convert them into clear action items.
  
• Willingness to learn regulatory requirements across different countries.
  

Benefits

• Opportunity to work with cutting-edge biological solutions in a fast-growing sector.
  
• Be part of an innovative biotech startup with growth opportunities.
  
• Continuous training and development in microbial and biological inputs.
  

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