Regulatory Specialist

Profile

Job Description
Plant Response Inc. is offering a position for its headquarters located at Durham, North Carolina.
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Plant Response Inc. is an agrobiological company focused on the identification and development of new molecules, microbes, and formulations regulating plant responses to biotic and abiotic stresses. Collaborations with leading worldwide research groups, best in class facilities, strong IP, broad portfolio products and a highly skilled team allows Plant Response to be one of the most innovative companies in the world.
More information can be found at: ****The Regulatory Specialist at Plant Response, reporting to the Director of Regulatory will support, manage, and accomplish the registration of agricultural products at Plant Response with U.S. states, international countries, and organic certifying entities. This objective will include new product registration, product renewals, and registration amendments. In accomplishing these tasks, supporting of the regulatory affairs of the company will involve communication with regulatory officials, cross functional team members, and industry partners. Further, compilation of documentation and data will be organized into clear and compliant registration dossiers to deliver registrations in a timely and predictable manner. Delivering the regulatory strategy of the company involves ensuring compliance of a diverse portfolio of products with worldwide agribusiness and chemicals regulations and contributing to the business development through sales authorizations.
Job Requirements
Major Responsibilities
• Management of the registration portfolio of fertilizer/soil amendments/biostimulants in the United States & Canada.
• Operational regulatory: New product submissions, product renewals, registrant updates, label changes, agency communication, label management, dossier preparation, alignment of product documentation with regulations
• Communication and stakeholder management across R&D, Manufacturing, Commercial, Operations
• Responsible for all aspects of obtaining and maintaining authority to sell a diverse portfolio of agricultural products
• Maintain compliance of all product registrations through effective and timely submissions/renewals for licenses, registrations, and tonnage reporting requirements.
• Evaluate proposed products for regulatory classification and process.
• Identify needs for regulatory processes or organizational platforms to allow for facile interface between regulatory approvals and technical and commercial teams.
• Monitors the progress of regulatory review processes through regulatory and appropriate communications with the agencies.
• Assist development of the regulatory strategy through development and planning of the regulatory processes, systems and activities according to the company’s expansion. Review company practices and provide advice on changes to processes and systems.
• Align regulatory costs and timings to deliver commercial strategy. Monitor regulatory affairs activities of Plant Response’s employees to ensure they are aligned with corporate strategy.
• Negotiate with regulatory authorities for marketing authorization. Provide responses to regulatory agencies regarding product information or issues.
• Coordinate scientific endeavors with regulatory demands throughout the life of each product, helping to maximize the cost-effective use of the company’s resources. Close relationships among product development, agronomy, commercial, R&D, formulations and supply departments to ensure everyone knows regulatory inputs.
• Support the development of products through key advice on cross-portfolio data and documentation development.
• Managing needed third party relationships: authorities, consultants, industry alliances and customers/partners.
• Government Affairs: positive influence to regulators and key stakeholders. Create a strong and trustable company image. Develop relationships with regulatory agencies.
• Specify storage, labelling and packaging requirements. Write clear, accessible product labels in coordination with technical and marketing teams.
Requirements
• Degree: BS in S.T.E.M., with preference for life-sciences (Agronomy, Biotechnology, Pharmacy, Agronomy, Biology, and similar).
• Experience: 2-5 years in agriculture or agbiotech companies (seeds, biotechnology, crop protection, fertilizers).
• Desired: Experience with registration of fertilizers, soil amendments, etc. at the U.S. State level
• Languages: English is a requirement; other languages will be valuable.
• Effective use of computers, ITs, systems and MS Office.
Profile Skills
• Proactive, transparent, strong attention to detail to establish efficient processes and maintain systems that deliver upon regulatory strategy and product registration.
• Drive for continuous improvement as well as technical and operational excellence. Results and business oriented.
• Ability to multitask and work independently with limited supervision, adapt to manage multiple tasks and respond to changing work situations and environments.
• Excellent interpersonal skills. Ability to work with multicultural teams in international environments.
• Tact and diplomacy to identify opportunities for improvement and solve problems. Cross-functional team leadership skills. Ability to work in close collaboration with others.
• Effective and convincing written and verbal communication skills: listening, negotiation and presentation skills.
• Analytical and decision-making skills. Translation of regulatory requirements into product strategy and practical plans. Ability to manage complex projects and teams to tight deadlines.
• Resourceful/Organizational/Planning and time-management skills. Establish regulatory priorities or budgets and allocate resources and workloads. Capacity to identify and determine relevance in order to coordinate and prioritize efforts accordingly.
• Strategic/critical thinking and assertiveness in negotiating situations.
We offer
• Immediate incorporation: Full time contract with attractive salary depending on experience and skills.
• You will be working in a modern, professional, fast growing internationally active organization with a high degree of responsibility and independence.
If you meet the requirements, and you are passionate about innovation, we encourage you to apply now: ****

Company info

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