Senior Director, Global Regulatory & Quality Affairs
Senior Director, Global Regulatory & Quality Affairs
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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 game-changing advances in fertilizer technology. Our first commercial product harnesses the power ofnaturally-occurringmicrobes modern gene editing and application technologies to provide nitrogen to crops. Weare dedicated to providingnew solutionsfor farmers to improve yield as they work to help feed the worlds growing population. Read/Hear more about Pivot Bio onForbesorPBS News Hour.
We are seeking a Senior Director Global Regulatory and Quality Affairs to lead the product registration quality controls and value demonstration needs of Pivot Bio. This role is instrumental in ensuring all regulatory approvals are in place in a timely manner our products meet the highest standards of quality and our customers see and experience the very best performance of Pivot Bio we bring this novel technology to farmers both in the US and globally a critical part of this role will be to oversee regulatory science data collection develop high value efficacy demonstration tools and techniques ensure quality standards are met and prepare high quality regulatory submissions and see them through to approval to enable commercialization and routine maintenance of Pivot Bio products label statuses.
The location of this position is preferred to be at our center of excellence located in St. Louis Mo.
Responsibilities:
- Meeting regulatory standards:Ensure products and processes meet the necessary safety quality and efficacy requirements mandated by regulatory bodies.
- Building trust:Meeting quality and regulatory standards building internal and external customer trust enhancing Pivot brand reputation to enhance customer satisfaction and and participate in the development of efficacy demonstration and communication strategies to help regulators and customers understand and witness the differentiating performance of Pivot products on farm
- Support of manufacturing and R&D teams to improve product reliability and support demonstration of product value to customers.
- Support continuous improvement efforts across the company helping Pivot adapt to changing market expectations and maintain a competitive edge.
- Facilitating global market access and expansion by enabling product approval through successful navigation of international federal and state regulatory submission processes ensuring products meet the requirements for market approval and facilitating quicker market access.
- Develop and execute on strategic agency and partner engagements on a regular basis
- 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 and impacts proactively to internal stakeholders.
- Develop strong understanding of our science and commercialization plans in order to ensure complete accurate and timely registrations and ensure product efficacy standards are met or exceeded.
- Prepare and maintain routine registration progress reports.
- Available for up to 20% travel required for team company agency and industry meetings.
Required Qualifications:
- Ph.D preferably in molecular biology microbiology or other agricultural relevant subjects
- 16 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 with emphasis on LATAM regions
- 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
- Project management experience is a plus
Travel:
- Up to 20% travel required to the field for regulatory consultations and team meetings.
Must be authorized to work in the United States
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:
Exec
Employment Type
Full Time
