Head of Global Regulatory Affairs

ABOUT GREENLIGHT

At GreenLight we are working to solve two of the world's greatest problems: global food insecurity and equal access to vaccines and the associated health benefits. Unlike most corporations who can be required to put profits ahead of other principles, GreenLight is one of the first Public Benefit Corporations to be publicly traded and have a charter that requires a focus on how it benefits its employees, community and society and has a broad portfolio addressing key issues in plant health and human health (Nasdaq: GRNA) by leveraging the full potential of dsRNA and mRNA. The GreenLight team is over 300 people across our headquarters in Medford, MA, an R&D facility in Woburn, MA and an R&D facility in Research Triangle Park, NC. GreenLight also has a biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity, protect bees and other pollinators, treat rare diseases as well as develop vaccines.

At GreenLight, we believe inclusion is the way forward. We celebrate the power of working together to address humanity’s challenges, meet the needs of underserved populations, and push the boundaries of scientific discovery. Fueled by our aspiration for a true sense of belonging, our talented teams embody the principles of diversity and equality as we strive to bring food security, medicine, and healthcare to everyone—paving the way for a sustainable future. For more information, visit www.greenlightbio.com.

Job Summary: The incumbent will be responsible for developing the organizational and operational strategies and processes that GreenLight will need to secure Plant Protection registrations of its products in the jurisdictions of interest.  The scope of work includes the development of all data and data waivers, including efficacy where required. to be used in regulatory dossiers. Additionally, the incumbent will need to develop, implement and drive strategies that protect GreenLight’s intellectual property, maximize data protection for products and allow us to work seamlessly with commercial partners who may wish to own their own registrations for Active Substances developed by GreenLight.  The incumbent will also work closely with GreenLight’s Government Affairs and Corporate Affairs to focus our lobbying activities to help position the regulatory oversight of dsRNA across all jurisdictions in the way that most bene fits the properties of the technology.  The incumbent will be accountable for agreeing to, and delivery of, all Registration timelines as well as driving the key metrics to drive and measure the number of ‘Right First Time Registrations’.

JOb Responsibilities:

Customer:

• Provide appropriate communication and guidance to management and other internal functional areas responsible for submitting required regulatory documentation.
• Advise the company on the regulatory aspects and climate that would affect proposed activities.
• Serve as primary regulatory representative responsible for facilitating all regulatory agency interactions.

• Leads the global regulatory team in, developing dossiers for new product solutions including due diligence activities.
• Assessment of resource needs to service the dossier requirements for GreenLight’s project portfolio.
• Establish regulatory strategy that allows for intimate integration of Regulatory needs for an Active Substance to be defined for all markets needed globally whilst eliminating study or end-point duplication.
• Further implement such strategy for product level registration.
• Manage and continually optimize Regulatory collaboration with the R&D group, Formulations, Global Marketing and external consultants and CROs as needed.
• Develop and provide clear strategic rationale for the most appropriate regulatory positioning for all dsRNA products (new lead candidates as well as new development products) and combined portfolio within the company.
• Ensure sufficient competence exists both within GreenLight and the CROs and Consultants we partner with to properly design and execute Registration studies and waivers.
• Ensure that continuously updated technical summaries of critical endpoints and classifications are available for all commercial and development triggers and products and that the data that under-pins such are readily available in a structured manner.

 Process/ Operation:

• Determine and deploy the optimal mix of internal and external regulatory support at the product country level.
• Lead the development of project level spending forecasts for Regulatory needs for budgeting and develop a real-time monthly spending forecast.
• Identify potential regulatory threats with sufficient lead-time to develop mitigation strategies.

 Individual/ Team:

• Identify opportunities to accelerate registration programs.
• Become THE industry luminary on the technical registration of products based off dsRNA.
• Provide leadership and develop Regulatory staff.

REQUIRED EDUCATION AND EXPERIENCE:

• A Master of Science or Ph.D. in a life science, toxicology, environmental or related field.
• 10+ years combined experience in a regulatory discipline is required with preference for some of the experience to be in a non-USA jurisdiction.
• Proven track record of project management with on-time and on-budget success.
• Strong understanding of Agrochemical Industry, Crop Science or Biotechnology.
• Proven success in leadership.
• Detailed knowledge of at least one of the key regulatory sciences such as Toxicology, Eco-Toxicology (preferred), E-Fate, Metabolism or Residues.
• Experience in registering Agro-chemicals and Biologicals as well as compiling, submitting and defending dossiers (including Reduced risk / GRAS submissions) for brand new Active Ingredients/Mode of Action.
• Proven capability in public speaking or government affairs preferred.

KEY COMPETENCIES:  

INFLUENCE: Success in this role will require partnership & collaboration through influence with senior management within the organization to execute the strategies that foster organizational effectiveness.

RESULTS ORIENTATION - Holds self and others accountable for accomplishing work commitments and deliverables and understands the targeted results he/she is accountable for and actively strives to achieve them.

COMMUNICATION - Speaks, writes, listens and presents information in a logical and articulate manner, appropriate for the audience; ensures that information is shared.

CREATIVITY – Approaches job responsibilities with an open mind, helps to identify novel solutions that improve processes, systems, products, or services.

PROBLEM SOLVING - Identifies root cause of a problem and works with others to permanently fix problems.

BUSINESS ACUMEN: The individual in this role must understand business priorities and translate them into an agenda that supports the business as it grows. 

ORGANIZATION/PROJECT MANGEMENT - Plan and schedule work according to changing priorities; designs and maintains effective systems and processes for managing work.

CUSTOMER FOCUS – Ability to building strong customer relationships and delivering customer-centric solutions.

DECISION MAKING - Makes thoughtful decisions and sound judgments based upon a clear understanding of problem or issue, relevant information, data, experience, business objectives and potential impact to GreenLight Biosciences.

ADAPTABILITY - Open to change; responds positively to new situations, obstacles, and opportunities.

PERSONAL DEVELOPMENT - Is self-motivated, has energy and drive, is self-aware, deals with challenges and takes ownership of personal development and growth.

Supervisory Responsibilities:

• Number of direct reports:  2+

• Number of indirect reports: TBD

• Budget responsibilities: $12M – 20M

Travel: 30% of the time; international travel will be required

Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

GreenLight requires proof of COVID-19 vaccination for its employees.