Sr. Director/VP of Regulatory
3 weeks ago
Nobell Foods is creating cheese and other dairy products from plant-derived dairy proteins for the 99% of people who are unwilling to compromise on taste and price. Nobell is made up of a team of passionate scientists, explorers, and storytellers on a mission to radically change the way we make food, so it’s better for you, the animals and the planet. We are backed by Bill Gates’ client fund Breakthrough Energy Ventures, Andreessen Horowitz, and Robert Downey Jr. If you believe in our mission and are excited about our work, we would love to hear from you
Your Role:
You will lead the company’s regulatory affairs, including developing and executing its regulatory strategy for its product development and commercialization activities. You will also be a key internal leader and driver of regulatory policy and strategy for our products and will provide regulatory guidance to executive leadership in all areas of regulatory affairs throughout the R&D, approval and commercialization phases of the product life cycle. You will also work closely with teams across the company to advise on regulatory strategy and field operations compliance, prepare and manage relevant submissions with USDA and FDA, as well as manage such relationships, and provide strategic and operational guidance based on your experience and expertise.
Responsibilities:
- Reporting to the Chief Legal Officer, this role will be responsible for developing and driving the execution of Nobell’s global regulatory strategy and providing leadership and oversight on all R&D, product development and commercialization activities at Nobell for a range of genetically engineered traits and products in soybean as well as the food products made from those soybeans.
- Shape, create alignment and execute the regulatory requirements and strategy for genetically engineered traits in development through to commercial launch in collaboration with the leadership team; serve as partner to internal teams on all regulatory matters specific to their functions.
- Serve as primary liaison with USDA, FDA and foreign counterparts; establish appropriate, proactive communications with agency officials to ensure expedient and efficient review and approval of submissions; lead meetings between Nobell and government agencies and prepare internal teams for such meetings.
- Provide strategic and technical guidance on regulatory submissions.
- Prepare and manage permits, applications and other submissions for all activities associated with the company’s plantings and field operations and commercialization activities at global level; work with internal teams on the preparation of data packages required for such submissions; provide regulatory review for all permits, applications and other submissions.
- Provide regulatory support for product commercialization process, including preparation of US GRAS and other international food safety evaluations, reviewing product labeling and marketing materials for compliance with applicable agency submissions and regulations and supporting the product release process.
- Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for the business and product pipeline in partnership with the legal and compliance teams.
- Serve as the company authority on agricultural biotechnology regulatory policies in the United States and other regions, (as needed) and play lead role in updating and preparing the company for any changes in legislation which impact the business.
- Build and manage a high performing regulatory team to support our product development and commercialization goals
- Lead company-wide regulatory training program in partnership with the Compliance team.
Qualifications
- An M.S. or Ph.D. in a field applicable to plant science
- Minimum 12+ years of relevant regulatory experience in agriculture industry
- Demonstrated ability to develop and maintain excellent working relationships with USDA and FDA, including experience obtaining USDA-APHIS BRS authorizations, designing, managing and submitting data packages and dossiers to USDA/APHIS and FDA and bringing products to market via US GRAS process
- Demonstrated experience working on regulated field trials in United States
- Experience building teams and establishing regulatory capabilities and functions
- Ability to understand and communicate complex scientific concepts and key issues to regulatory agencies and internal multidisciplinary teams
- Excellent interpersonal and communication skills to partner with internal teams to drive regulatory strategy in combination with business objectives and facilitate collaboration across functions and build successful relationships with internal and external stakeholders
- Entrepreneurial thinker and attitude, creative problem solver and comfortable working within a fast-paced, high-growth company
Closing:
The pay range is currently between $177,000 to $265,000 in annual gross compensation for a Senior Director level role in the Bay Area and between $199,000 to $319,00 in annual gross compensation for a VP level role in the Bay Area. Within the range, individual pay is determined by many factors, including job-related skills, experience, and relevant education or training.
Nobell Foods offers competitive compensation, generous healthcare, dental and vision plans, 401(k) and commuter benefits.
Full time, South San Francisco, CA or Remote
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