Elo Life Systems
Position Description – Director of Regulatory Affairs

Elo Life Systems (“Elo”) is rethinking and empowering the future of sustainable healthy food. Using its precision breeding technologies, genomics and data analytics, machine learning, gene editing capabilities, and agronomic expertise, Elo creates innovative plant-based foods that are good for you and good for the planet.

The company is currently advancing its first products from R&D to field testing and building relationships with commercial partners to evaluate and design whole new applications in the food and beverage industry. For example, Elo has created a natural low-calorie sweetener that has broad application as a healthier (and tastier) substitute for sugar and harmful artificial sweeteners. And in partnership with Dole, Elo is protecting important foods against destructive diseases, such as the rapidly spreading Banana Fusarium wilt caused by Fusarium oxysporum f. sp. cubense tropical race 4 (TR4) fungus, which is decimating the world-wide production of bananas.

With its R&D engine fully primed, the company is developing plans to launch multiple new commercial products over the next five years. And we are evaluating even more new R&D opportunities that further our mission to improve nutrition and sustainability through innovative foods.

Elo’s core values reflect the importance of its mission and the motivations of its teams, which are needed to tackle the toughest challenges. The company is looking for individuals with diverse backgrounds that exemplify the same.

Creativity.
We empower imagination and risk-taking that shatters conventional wisdom.

Trust.
We achieve durable success by building open and collaborative relationships with our colleagues, commercial partners, and consumers.

Excellence.
Our products feed families, so our dedication to meeting the highest standards must never waiver.

Momentum.
The product of people and velocity, which allows a small object to exert tremendous force. With our team in motion, nothing can stop us.

Elo Life Systems is located in Research Triangle Park, NC, a world-renowned Ag Tech center. This position is expected to travel 30-40%. Please send your application to careers@elolife.ag.

The Role

The Director of Regulatory Affairs will be responsible for designing and executing the global regulatory strategy for Elo’s biotech crops and food products, and building the regulatory capabilities at Elo. They will be managing internal and external regulatory sciences/affairs resources to define the approval pathways for Elo’s products, coordinate the required field testing and related studies, draft and submit regulatory filings, ensure Elo’s compliance with all applicable regulatory laws and regulations, and advocate on behalf of Elo with regulatory agencies around the world. The ideal candidate will have a deep understanding of the regulatory processes and requirements for food products and biotech crops, experience building and leading regulatory teams, and a history of effective interactions with global regulatory agencies.

Key Competencies:

  • Ability to translate and articulate complex scientific and regulatory concepts to senior management and Board of Directors to enable business decisions and prioritization of resources.
  • Deep understanding of regulations impacting foods, food additives, and ingredients (biotech reviews, labeling requirements, GRAS panels, etc.), and the intersection of those regulations with Elo’s gene-edited and biotech products.
  • Comfort making decisions when faced with uncertainty and ambiguity, e.g., when existing laws and regulations have not anticipated the latest technological advancements.
  • Strategic thinker that anticipates questions and challenges from regulators, and proactively plans and generates data well in advance to address those issues.
  • Leverages a broad professional network and maintains relationships in the industry to drive success.
  • Always learning and stays current with changes in the industry that impact registration/approval of biotech products and foods.
  • Seeks creative solutions that are backed by data. Strong research, problem solving, and decisionmaking skills.
  • Excellent interpersonal and communication skills.
  • Collaborative approach leading teams; confidence driving results within matrixed organizations. Leads by inspiring trust.
  • Demonstrates accountability, responsibility, and integrity in every aspect of professional life at Elo and upholds Elo’s values in all they do.

Key Responsibilities:

  • Build and manage the global regulatory capabilities at Elo using internal and external regulatory sciences/affairs resources.
  • Develop and implement the regulatory strategy for approval/registration/labeling of Elo’s biotech crops and food products.
  • Design and oversee required regulatory field testing and other studies needed to secure approval/registration/labeling of Elo’s products; ensure data quality and compliance with all laws and regulations.
  • Working with internal and external resources, draft and submit regulatory filings.
  • Interact with regulatory agencies around the world on behalf of Elo.
  • Implement stewardship and compliance programs/protocols to ensure Elo’s products and activities comply with all applicable laws and regulations. Provide training to Elo personnel and vendors to meet applicable requirements and develop a culture of compliance.
  • Keep senior management apprised of developments and opportunities with global regulatory systems impacting biotech crops and food products, including SECURE rule changes at USDA, and the latest processes/requirements being implemented by USDA.
  • Demonstrates accountability, responsibility, and integrity in every aspect of professional life at Elo, while upholding Company values
  • First-hand experience managing GRAS panels and biotech reviews with U.S. FDA, preparing RSR submissions to USDA under the SECURE rule, and overseeing regulated biotech crop field trials, are preferred.
  • Regulatory experience involving biotech and gene-edited applications in fruits and vegetables is a plus.

The Successful Applicant

  • A PhD in plant biology, genetics, biochemistry, or related fields.
  • 10+ years of regulatory experience with biotech crops and foods.
  • Prior experience in a fast-paced technology company a plus

Compensation

We offer a very competitive compensation package, consisting of salary, bonus, equity, and benefits to all team members. For health benefits we pay 100% coverage for employees and their family members!

Elo Life Systems, Inc. is proud to be an affirmative action / equal opportunity employer. All qualified applicants will receive consideration without regard to race, creed, gender, marital status, sexual orientation, citizenship status, color, religion, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.

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