Scientist, Global Regulatory Affairs

Job Summary: 

Work with global regulatory managers to develop regulatory strategy and build regulatory dossiers for submission.  Work closely with project teams in development of a new compound.  Interact with discovery, bioinformatics and formulation teams to provide scientific clarity in the regulatory submission.  Ensure that all scientific areas relating to RNAi are adequately addressed in a regulatory submission and respond to questions raised by regulatory authorities. Maintain an awareness of the scientific developments surrounding RNAi.  Presentations of RNA technology to regulators.

Job Responsibilities: 

• Participate in GreenLight project teams
• Pro-actively address any potential concerns related to a regulatory submission
• Present to regulatory authorities
• Address any questions from regulatory authorities on RNA technology
• Recognized as RNA technical expert within Global Regulatory team
• Build relationships with universities and academic institutes to maintain GreenLights leadership position in RNAi technology

REQUIRED EXPERIENCE:

• Solid RNAi background (plant focused but mammalian/human therapeutics also useful)
• 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.
• Science degree in life sciences and Ph.D in molecular biology preferred

Location:  Research Triangle Park, NC North America

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.