Sr. Regulatory Manager, Biotic Products

Indigo improves grower profitability, environmental sustainability, and consumer health through the use of natural microbiology and digital technologies. Utilizing beneficial plant microbes and agronomic insights, Indigo works with growers to sustainably produce high quality harvests. The company then connects growers and buyers directly to bring these harvests to market. Working across the supply chain, Indigo is forwarding its mission of harnessing nature to help farmers sustainably feed the planet. The company is headquartered in Boston, MA, with additional offices in Memphis, TN, Research Triangle Park, NC, Sydney, Australia, Buenos Aires, Argentina, and São Paulo, Brazil. www.indigoag.com

The role of Senior Regulatory Manager, Biotic Products is responsible for the development, management, coordination and completion of government, regulatory and compliance documents and submissions as they relate to biotic products registration, and for the execution of the federal registration of these products in the United States.

 

Responsibilities:

  • Execute and manage Federal and State registrations of Indigo biotic / biocontrol products in United States. Develop rationales and dossiers needed to execute the registrations
  • Become an internal business partner to Indigo early / mid stage R&D, to provide guidance and ensure that necessary data is developed early on to support successful federal registrations submissions of Indigo biotic products
  • Manage working relationships and effective communications with government agencies involved
  • Manage and prioritize numerous product registrations simultaneously through effective communication with internal and external stakeholders
  • As required by federal 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
  • Remain educated and informed on biocontrol regulatory issues in the industry.
  • Develop and maintain relationships with the Biotic team and other key stakeholders, obtain a deep understanding of Biotic TPPs (Target Product Profile) and deliverables

 

Competencies:

  • Passion for agriculture and sustainable solutions 
  • Able to think creatively and strategically
  • Solutions-oriented
  • Strong record keeping, organizing and multitasking skills
  • Well-structured communication skills and technical writing capabilities
  • Team-oriented style and strong work ethic
  • High standards for self and the team around them
  • Strong EQ (interpersonal, communication and relationship building skills); appropriate balance of confidence and humility
  • Able to gain consensus working collaboratively and cross-functionally with internal and external parties
  • Able to iterate, learn and adapt quickly as the regulatory and technology landscapes evolve; extremely agile
  • Able to prioritize to address conflicting demands

 

Qualifications:

  • Master’s degree in microbiology, molecular biology, environmental science or related
  • Plant pathology or entomology experience nice-to-have
  • Minimum of 5 years professional experience working with biological products regulatory affairs, especially with FIFRA/EPA, and USDA
  • Strong expertise with respect to current Federal and State regulations landscape for agriculture products
  • Strong working relationships with Federal agencies who oversee biotic product registrations
  • Able to be based in Boston with occasional travel

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