Regulatory Manager

GreenLight Biosciences is seeking a highly motivated Regulatory Affairs Manager to join our Crop Protection team. Greenlight is developing cutting edge RNA technologies that address key challenges in global Crop Protection. In this role you will be integrally involved in the development and registration of novel biochemical products. The ideal candidate will have registration experience as well as knowledge of biochemical product regulations. Strong technical, organizational, and communication skills, attention to detail, as well as the ability to maintain a commitment to excellence and high-quality work in a fast-paced milestone driven company, are essential.

DUTIES AND RESPONSIBILITIES:

• Participate in GreenLight project teams
• Prepare, submit and manage high quality scientific dossiers in accordance with relevant legislation.
• Serve as primary regulatory representative responsible for facilitating all regulatory agency interactions for assigned projects/products.
• Work with CROs and Consultants to design and execute Registration studies and waivers.
• Pro-actively address any potential concerns related to a regulatory submission
• Ensure regulatory compliance throughout launch and commercialization of products.
• Present to regulatory authorities
• Address any questions from regulatory authorities on RNA technology

SKILL SETS

•  Strong technical and communication/influencing skills to work with internal GLB functions, regulatory authorities and industry associations.  
• Ability to “translate” complex scientific topics to different audiences
• Experimental planning and project management skills
• Initiative leadership to address potential concerns in studies, regulator questions etc regarding RNA technology
• Solution orientation – Leadership in addressing perceived issues in GLB products
• Willingness and ability to learn and explain clearly developing scientific advances in RNA  
• Strong Collaboration skills and a positive approach to working with different internal teams and external stakeholders.

QUALIFICATIONS:

• Science degree in life sciences and 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.
• Detailed knowledge of at least one of the key regulatory sciences such as Toxicology, Eco-Toxicology, E-Fate, Metabolism or Residues.
• Experience in registering Agro-chemicals and Biologicals.