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Global Regulatory Manager


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Job Title: Global Regulatory Manager
Location: Durham, NC, South United States, USA
Company: Syngenta
Industry Sector: Agribusiness
Industry Type: Plant & Soil Sciences, Seed & Biotechnology
Career Type: Business Development/Strategic Management
Job Type: Full Time
Minimum Years Experience Required: N/A
Salary: Competitive
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About Syngenta

 

Syngenta is a global leader in agriculture; rooted in science and dedicated to bringing plant potential to life. Each of our 51,000 employees in more than 90 countries work together to solve one of humanity’s most pressing challenges: growing more food with fewer resources. A diverse workforce and an inclusive workplace environment are enablers of our ambition to be the most collaborative and trusted team in agriculture. Our employees reflect the diversity of our customers, the markets where we operate and the communities which we serve. No matter what your position, you will have a vital role in safely feeding the world and taking care of our planet. Join us and help shape the future of agriculture.

 

About Us

 

Through leading innovations, we help farmers around the world meet the challenge of feeding a growing population and taking care of our planet. We are currently seeking a Global Regulatory Manager for the Seeds and Traits Regulatory team in Research Triangle Park, Raleigh-Durham, North Carolina. As a Global Regulatory Manager, you will obtain and maintain license and freedom to sell Syngenta’s biotechnology products.

 

You will help meet the world’s most pressing needs by:

    Providing regulatory advice to country business teams and lead regulatory projects to obtain and defend product approvals globally in over 20 countries Driving the development of strategies for obtaining global regulatory approvals of new biotechnology products Leading regulatory project sub-teams responsible for developing and delivering a detailed regulatory strategy and project plan for individual seed biotechnology products

Accountabilities

    Engage on project teams, contribute to overall strategy, and provide regulatory support for development and marketing of new seed biotechnology products Serve as regulatory business partner for the business traits project teams Develop and maintain in-depth knowledge of biotech regulatory requirements Identify and define global requirements for dossier content together with Regional Regulatory Heads and Country Regulatory Managers Monitor the progress of applications through regulatory review processes and provide technical support for regulatory dossiers to Country Regulatory Managers, including drafting responses to questions from regulatory agencies when appropriate Interact with regulatory agencies on defined matters  Ensure optimal information exchange on regulatory issues related to the project with key stakeholders Accountable for ensuring that all necessary project documentation is developed, implemented in a timely manner, managed, maintained current and archived in accordance with global Seeds Regulatory standards and Syngenta policies Communicate changes in the Regulatory Project Plan to the Regulatory Sub-Team members, the business, and other project team stakeholders Provide input on design and reporting of studies for use in regulatory dossiers Ensure review of regulatory protocols and studies Participate in the management of post-approval regulatory requirements Serve as Syngenta representative in industry association efforts related to agricultural biotechnology as needed


Requirements

    Bachelor’s degree or equivalent in Agricultural Engineering, Agricultural Studies, or a related scientific field 5+ years related progressive, post-baccalaureate experience with regulated biotechnology products 24+ months of global experience with international biotechnology regulatory requirements 12+ months of experience with each of the following experience may have been gained concurrently: Preparing biotechnology product applications for regulatory agencies and interacting with regulatory agencies Working in cross-functional and international teams Providing input on design, implementation, analysis, and reporting of agricultural studies Management of biotechnology regulatory trait projects Must be authorized to work for Syngenta in the United States without work authorization sponsorship

Preferred Requirements

    Knowledge of a broad range of scientific disciplines including molecular biology, plant molecular biology, general agricultural science, and food and feed and environmental risk assessments to ensure coordination of a comprehensive high quality data package that is applicable to be used for submission to regulatory agencies globally Ability to use knowledge of agricultural and scientific concepts to coordinate dossier preparation, lead technical discussions with technical experts and global regulatory colleagues, and interpret and communicate technical topics to internal and external stakeholders   

What We Offer:

    Full Benefit Package Medical, Dental & Vision that starts the same day you do 401k plan with company match, Profit Sharing & Retirement Savings Contribution Paid Vacation, 12 Paid Holidays, Maternity and Paternity Leave, Education Assistance, Wellness Programs, Corporate Discounts among others A culture that promotes work/life balance, celebrates diversity and offers numerous family-oriented events throughout the year

 

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, marital or veteran status, disability, or any other legally protected status.

 

Family and Medical Leave Act FMLA

 

Equal Employment Opportunity Commission's EEOC

 

Employee Polygraph Protection Act EPPA

 

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Job Post Date: 09/02/21
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