Global Regulatory Manager

Role purpose

Lead Seeds and Traits & Regulatory sub-teams under the direction of the Global Regulatory Traits   Development Lead to obtain and maintain license and freedom to sell for all of Syngenta's products. Provide regulatory advice to the country business teams and lead regulatory projects to obtain and defend product approvals globally.

Accountabilities

• Overall responsibility: obtain and maintain license and freedom to sell for a number of Syngenta's  products.
• Provide regulatory and stewardship advice to the business and lead regulatory projects,  compliance and/or operational activities.
• More precisely, responsibilities for this role include:      
• Drive  the development of strategies for obtainining global regulatory approvals of new biotechnology traits, supporting Business Team objectives.
• Lead regulatory project sub-teams responsible for developing and delivering a detailed regulatory strategy and project plan for individual seed products.
• Engage on project teams, contribute to overall strategy and provide regulatory support for development and marketing of new seed products. Regulatory business partner for the business traits project teams.
• Develop and maintain indepth 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 draft responses to questions from regulatory agencies when appropriate.
• Interact with regulatory agencies on defined matters.
• Ensure optimal communication/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 any changes in the Regulatory Project Plan to the Regulatory Sub-Team members.
• Provide input on design and reporting of studies for use in regulatory dossiers. 
• Participate in the management of post-approval regulatory activities.
• Participate in industry association efforts related to agricultural biotechnology as needed.

 

Knowledge, experience & capabilities

Critical knowledge

•    Masters of PhD degree in Agricultural Studies or in a relevant biological field e.g. molecular biology, biochemistry, toxicology, entomology, plant breeding, etc.;  •    Knowledge of a broad range of scientific disciplines including:  molecular biology, plant molecular biology, general agricultural science; familiarity with plant breeding and agricultural production desired. Critical experience

•    Five years of work experience with regulated products, through prior position in industry, academia, or government institution. •    Strong capabilities in the interpretation and communication of technical topics to internal and external stakeholders. •    Ability to provide input on design and reporting of studies for use in regulatory dossiers and ability to collaborate with technical team members who are accountable for these studies. •    Demonstrated ability to work successfully on cross functional teams to ensure delivery of GM trait projects and to support critical and timely decision-making. •    Experience with the complexity of integrating research, commercial, and regulatory knowledge to achieve business goals. •    Ability to independently prepare succinct, scientifically accurate, and clearly written technical and regulatory documents. •    Strong affinity with data management systems.

Critical technical, professional and personal capabilities

•    Work independent within an international environment •    Analytical, attention to detail •    Proactive, self-motivating, decisive, ability to work under pressure •    Ability to communicate and interact within diverse environments colleagues, decision makers, competitors etc. and work within a team. Strong communication skills, ability to convince people, ability to listen. Critical leadership capabilities

•    Strong analytical skills with the ability to understand and prioritize information and to interpret and apply business needs •    Is dedicated to meeting the expectations and requirements of internal and external customers.

Additional information   •    Ability to work with projects, team player. •    Willingness to travel from time to time. •    Flexibility in working hours, implementation of knowledge and experience. •    Creative behaviour in cooperation with colleagues from acquired companies and in other re-gions.

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  Open Vacation Policy with a minimum of 15 days of vacation and up to 30 days with manager approval, 9 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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