Regulatory Scientist

Job Description

Syngenta Group is the world's leading agricultural innovation company. Syngenta Group China is one of the four major business segments of Syngenta Group and a leading company in the field of modern agricultural of China.

Syngenta’s China Regulatory Science is committed to applying world-class science and winning innovation to offer farmers safe, cost-effective solutions that address the demands of a rapidly changing world.  As a Regulatory Scientist, you will design, execute, and oversee protein characterization studies and perform analytical method validations and study reports to support regulatory submissions of Syngenta's genetically modified (GM) crops and products developed through New Genomic Technologies (NGT), including gene editing.  You will provide technical guidance and scientific advice across broad areas of expertise in protein biochemistry and/or analytical science and will work with cross-functional teams to support development of GM and NGT crop products and to interpret and apply safety assessments required by regulatory authorities for product approval and maintenance. Specific responsibilities include but are not limited to the following matters:

Role purpose / Accountabilities

You will:

• Independently plan, design, execute, monitor and deliver protein characterization studies in support of safety assessments of our biotech crops in compliance with all safety, regulatory, and relevant quality system, e.g. ISO requirements.
• Characterize microbial and plant proteins from different and complex matrices using standard biochemical methods like protein quantitation, SDS-PAGE, Western blot, glycosylation analysis, enzyme activity assessments
• Develop and validate methods (e.g., enzymatic activity methods, protein extraction methods) for application in plant protein analytical and protein characterization studies
• Document experiments and results, interpret data, and write and review complex technical documents (protocols, reports, Standard Operating Procedures (SOPs), guidance documents).
• Play an active role in identifying, solving, and managing a variety of technical issues or challenges.
• Identify risks to Syngenta products and contribute to the development, communication, and implementation of risk management and mitigation plans.
• Be able to understand and communicate technical issues with stakeholders and provide expert input and/or prepare technical documents in response to questions from regulatory authorities.
• Ensure technical procedures are aligned with regulatory expectations and meet international standards.
• Serve as Study Manager accountable for timely delivery of studies conducted as part of comprehensive regulatory data packages in support of the global registration of biotech food crops.
• Stay at the forefront of technological and techno-regulatory advancements to enhance and maintain technical expertise, deliver maximum value for Syngenta, and establish yourself as a trusted subject matter expert. 
• Manage and prioritize multiple project responsibilities within cross functional teams for timely delivery.

Qualifications

Critical success factors & key challenges

• Ability to make good technical judgements in a timely manner
• Ability to gain the confidence and trust of internal stakeholders
• Ability to lead small projects and to deliver technical leadership in defined areas
• Ability to facilitate constructive discussion and resolution of complex technical issues
• Ability to establish oneself as a credible and recognized technical expert internally and externally
• Ability to collaborate effectively and efficiently with staff at all levels within Syngenta
• Ability to work on multiple projects simultaneously and to prioritize work effectively
• Effective written/verbal communication, organizational, and analytical skills
• Strong interpersonal and influencing skills
• Commitment to continuous learning and development.

Critical Knowledge, experience, capabilities and qualifications

• A PhD, or equivalent combination of education and experience, with at least 8 years relevant professional experience in in Protein Biochemistry, Plant Physiology, Analytical Science or related fields
• Experience in developing protocols for purifying active proteins from different food crop plant and other complex matrices
• Demonstrated proficiency of basic laboratory techniques, including but not limited to total protein quantitation, SDS-PAGE, Western blotting, glycosylation analysis, enzyme activity assessments
• Experience with the development and validation of protein analytical methods, like enzyme assays and ELISA
• Ability to write complex technical documents, such as protocols, reports and SOPs, to globally recognized quality standards, e.g. ISO or GLP, and in a clear and easy to understand manner.
• A proven track record of solving difficult and complex technical problems
• Maintain and improve highest quality working standards.
• The ideal candidate will have prior experience with genetically modified or genome editing crops, including experience with toxicity and/or animal feeding studies in compliance with regulatory requirements.
• Experience authoring scientific/regulatory documents and able to clearly communicate complex findings.

Additional Information

Note: Syngenta is an Equal Opportunity Employer and does not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

 To learn more visit: www.syngenta.com