Position Summary
Pairwise is a mission-driven food+tech company dedicated to building a healthier world through better fruits and vegetables. Pairwise was founded in 2017 by leading academics and investors and applies the Nobel-prize winning gene-editing technology to deliver consumer focused innovation in fresh food choices. Pairwise is developing new types of leafy greens, berries, and stone fruit, with the first product expected in early 2022. Our team is backed by collaborative relationships with Bayer, recently closed $90 MM in funding, and is primed to deliver new varieties of produce through one of the best gene-editing platforms in food and agriculture. Pairwise is based in the start-up friendly Research Triangle Park area of North Carolina.
This position will report to the Lead of Regulatory and Quality and will work closely with scientific teams, external stakeholders, and regulators to generate compliant and scientifically supported documentation and submissions to enable product development and commercialization.
A well-qualified candidate has a graduate degree in biology or related field, experience in biotechnology regulations and regulatory affairs, and exceptional relationship and communication skills. The role requires high attention to detail, initiative and foresight and the ability to work independently and achieve results. The ideal candidate is a reliable and competent leader who can work inside and outside the organization to enable business success. This role resides in NC.
Essential functions
- Coordination and execution of high-quality submissions and documentation to satisfy pre-market and post-market regulations for gene-edited produce and enable on-time product launches.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review.
- Advise teams through required processes and develop or conduct regulatory training as needed.
- Create and execute product regulatory strategies by anticipating issues and having systems in place to mitigate risks and maintain product regulatory freedom to operate.
- Represent company in trade association regulatory committees as needed; provide input into policy development, draft public comments and monitor relevant regulations.
- Travel 10-20% percent.
Required Education and Experience
- 5+ years of experience working in agricultural biotechnology regulatory or similar
- BS in biology or related, graduate degree preferred
- Experience leading teams to create data needed, write submissions, correspond with regulatory authority, and guide internal teams
- Experience interacting with regulators, trade associations and related stakeholders
- Strong written and verbal communicator
- Excellent relationship and networking skills
- Strong analytical talent and ability to spot issues and develop strategies to address them
- Independent worker and highly results oriented
- Outstanding at finding win-win solutions to create company success