Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
About Pivot Bio:
Fueled by an innovative drive and a deep understanding of microbiology genomics crop nutrition and agriculture Pivot Bio is pioneering gamechanging advances in fertilizer technology. Our first commercial product harnesses the power of naturallyoccurring microbes modern gene editing and application technologies to provide nitrogen to crops. We are dedicated to providing new solutions for farmers to improve yield as they work to help feed the worlds growing population. Read/Hear more about Pivot Bio onForbesorPBS 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 agriculturalproduct regulated environment. Occasional travel will be required for external engagements team/company meetings and conferences.
Responsibilities:
- Enable the commercialization of Pivot Bios 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 thoughtleader 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
- Selfdriven 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 employerpaid premiums
- Life ShortTerm and LongTerm 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
#LIHybrid
All remote positions and those not located in our Berkeley facility are paid based on National Benchmark data. Following employment growth beyond the hiring range is possible based on performance.
Required Experience:
Manager
Employment Type
Full Time
