Senior Regulatory Manager, Toxicology

Indigo is a company dedicated to harnessing nature to help farmers sustainably feed the planet. With a vision of creating a world where farming is an economically desirable and accessible profession, Indigo works alongside its growers to apply natural approaches, conserve resources for future generations, and grow healthy food for all. Indigo’s Biological Products, Marketplace, and Carbon offerings improve grower profitability, environmental sustainability, and consumer health. Indigo Marketplace is a platform connecting growers with a network of buyers to secure optimal prices for their crops and offers hands-on control of a grower’s business through a range of pricing tools, real-time national bid discovery, and automated grain sales. Indigo Carbon, is a platform paying growers for increases in soil carbon content and decreases in greenhouse gas emissions. It helps growers realize additional revenue, healthier soils, and a more resilient farm by participation in a market of high-quality carbon credits – supported by rigorous quantification standards. The company is headquartered in Boston, MA, with additional offices in Memphis, TN, Research Triangle Park, NC, Basel, Switzerland, Buenos Aires, Argentina, and São Paulo, Brazil.

Indigo’s Biological Products organization develops products based upon our deep understanding of the plant microbiome. The company has commercialized such products for cotton, wheat, barley, corn, soybeans, and rice in North America, Latin America, and Europe under the biotrinsic™ brand. Our R&D and product development teams are working to continue to develop products that address the growing number of abiotic and biotic stresses that crops experience worldwide.

The role of Senior Regulatory Manager, Toxicology is responsible for the toxicology and risk assessments strategies for agricultural biological product candidates, management and interpretation of toxicology and biosafety studies and their outcomes, to enable scientifically strong registration submissions and registrations of such products globally.

This role is located in the European Headquarters in Basel, Switzerland - the place of work is flexible and can be agreed upon for the right candidate. 

Responsibilities:

• Develop and execute safety strategy for biological products to ensure product stewardship and compliance
• As required by regulatory requirements and guidelines, oversee the projects assigned to the contract laboratories (product testing, safety / tox studies, efficacy testing, ecological effects testing and subsequent reports) to ensure quality and timely outcome.
• Develop human, animal, and environmental risk assessments and rationales for dossiers using expertise and interpretation of safety studies conducted to execute and defend the product registrations.
• Manage working relationships and effective communication with regulatory officials and stakeholder groups to discuss and resolve scientific issues
• Manage and prioritize numerous projects simultaneously through effective communication with Global Director of Regulatory Sciences, VP of Regulatory, internal, and external stakeholders.
• Remain educated and informed on the most up-to-date regulatory issues, testing methods, and rationales used in the agricultural industry

Competencies:

• Passion for Agriculture and Sustainable solutions 
• Able to negotiate and gain consensus working collaboratively and cross-functionally with internal & external parties
• Ability to iterate, learn, and adapt quickly as the regulatory and technology landscapes evolve
• Great working relationships with government agencies who oversee risk assessments during registrations
• Strong and creative strategic thinking and technical writing skills
• Solutions oriented with strong, proactive, problem-solving skills
• Strong record keeping, organizing, and multitasking skills
• Well-structured communication skills with team-oriented style and strong work ethic
• High standards for self and the team around with an appropriate balance of confidence and humility
• Strong EQ (interpersonal, communication and relationship building skills)
• Ability to operate in a multicultural and diverse environment

Qualifications:

• MS/PhD degree with emphasis on toxicology, environmental sciences, microbiology, or related fields
• Minimum of 5 -10 years of hands-on expertise working with current agricultural biological regulations especially human health & ecological risk assessments, globally
• Great working relationships with government agencies who oversee risk assessments during registrations

Indigo is committed to living our values, specifically “creating a work environment where everyone feels respected, connected, and has opportunities to learn and grow.” As part of living our values, we strive to create a diverse and inclusive work environment where everyone feels they can be themselves and has an equal opportunity of succeeding.