Regulatory Affairs Manager

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Requirements:

• B.S., preferably in molecular biology, microbiology, or other relevant subjects
• 8 years of relevant experience with scientific and regulatory affairs in the ag input industry; specific expertise with microbial biofertilizers is a plus
• Knowledge of international regulations of agricultural products in countries outside the US is a plus
• Project management experience is a plus
• Self-driven and able to manage multiple and changing priorities
• Strategic thinker with exceptional attention to detail
• Strong interpersonal, written, and oral communication skills
• Available for up to 20% travel for team, company, agency, and industry meetings
• Must be authorized to work in the United States

Responsibilities:

• Enable the commercialization of Pivot Bio’s products by ensuring regulatory clearance with the appropriate regulatory authorities in the US
• Develop, submit, and monitor regulatory documents to ensure the achievement of key deliverables, such as USDA LNJ and LNPR letters, AIR determinations, and permit issuances as needed
• Develop and execute on strategic agency engagements on a regular basis
• Act as a thought-leader in industry engagements and committees aimed at influencing regulatory bodies
• Stay informed about global policies and guidelines regarding microbial biofertilizer regulations and communicate changes to the Global Regulatory Policy & Registration team
• Collaborate with Regulatory Science, Product Biosafety, and other functions to ensure timely compliance with product regulatory requirements