Regulatory Affairs Manager

About Pivot Bio:  

Fueled by an innovative drive and a deep understanding of the soil microbiome, Pivot Bio is pioneering game-changing advances in agriculture. Our first commercial product harnesses the power of naturally-occurring microbes to provide nutrients to crops. We are dedicated to providing new sustainable ways for farmers to improve yield as they work to help feed the world’s growing population. Read/Hear more about Pivot Bio on Forbes or PBS News Hour.

Pivot Bio is seeking a Regulatory Affairs Manager who will be an integral part of the Global Regulatory Policy & Registration Team. Reporting to the Director, Regulatory Science and Operations, this role will be responsible for ensuring leadership in regulatory agency and industry engagement in the US. The ideal candidate has experience working in the agricultural-product regulated environment. Occasional travel will be required for external engagements, team/company meetings, and conferences. 

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 

• A thought-leader in industry engagements and committees aimed at influencing regulatory bodies 

• Keep abreast of global policies and guidelines as they relate to the regulatory policies of microbial biofertilizer products around the world and communicate potential changes to the Global Regulatory Policy & Registration team and other internal stakeholders. 

• Liaise with Regulatory Science, Product Biosafety, and other functions to ensure product regulatory requirements are appropriately met in a timely manner 

Required Qualifications:  

• BS, 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 other 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 an exceptional attention to detail 

• Strong interpersonal, written, and oral communication skills 

• Available for up to 20% travel required for team, company, agency, and industry meetings 

Must be authorized to work in the United States  

What we offer: 

• Competitive package in a disruptive startup 
• Stock options 
• Health/Dental/Vision insurance with employer-paid premiums 
• Life, Short-Term and Long-Term Disability policies 
• Employee Assistance Program with free referrals and discounts 
• 401(k) plan, 3% Match 
• Commuter benefits 
• Annual Training & Development support 
• Flexible vacation policy with a generous holiday schedule 
• Exciting opportunity to work with a talented and fun team