Regulatory Affairs Associate Ag Biologicals and Microbial Products
Job Summary
- 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.
- 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.
- 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.
- 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.
- 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.
- Bachelors degree in Microbiology Biotechnology Biology Agricultural Science Life Sciences or a related field.
- Approximately 12 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.
- 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.
- 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.
Required Skills:
Approximately 12 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.
Required Education:
Bachelors degree in Microbiology Biotechnology Biology Agricultural Science Life Sciences or a related field.