Trabajos

    Regulatory Affairs Manager - Buenos Aires, Argentina - HELM AG

    HELM AG
    HELM AG Buenos Aires, Argentina

    hace 1 semana

    Default job background
    Descripción

    Helm Argentina, a multinational Crop Protection company, is looking for talent to work as a Regulatory Affairs Manager

    Main Tasks and objectives:

    Development of regulatory strategy (including risk assessment) for assigned active ingredients and products
    - Obtaining and maintaining registrations of assigned active ingredients and products according to submission plan
    - Coordination of data gap analysis and submission dossier with input from global scientific experts and if necessary with external consultants
    - Planning and coordination of meetings with stakeholders and competent authorities, e.g. pre-submission meeting
    - Follow up post-submission and -registration requestes from authorities
    - Maintain CroPA Reg Info including projects under development
    - Set and update marketability entries in PS&S module of SAP

    Individual Tasks:

    Active representation in professional and scientific associations and panels
    - Extending and maintaining up-to-date regulatory intelligence (technical and legislative processes) including advanced crop solutions

    Responsible for:

    Shortening time to market by designing fast track registration strategies
    - Communication of registered label together with expected profit (GGP) together with crop manager / sales across enterprenerial unit
    - Compliance with applicable regulations including changes with potential regulatory impact for assigned active ingredients and products (global regulatory inventory)
    - Following regulatory trends of renewal/ban of active ingredients in Argentina (regulatorywatch)

    -Support to strategic partners to develop and register value added, IP and biological products

    Required professional background & qualifications:

    University degree in biology, chemistry, life science or agronomy
    - At least 3 years experience in regulatory affairs in either agro industry, consulting company and/or competent authority
    - Sound knowledge of processes for registration of plant prodution products and active ingredients in Argentina

    English (business fluent)

    Required Knowledge:

    Up-to-date knowledge of regulatory requirements for authorization of products including advanced crop solutions in Argentina
    - General understanding of the different sections of dossier in close exchange with scitific experts
    - Contractual frameworks with partners (contracts, confidentiality and data sharing agreements)

    Required Tool Know How:

    SAP (PO, SES, VIM, PS&S, QC)
    - MS Office incl. MS Teams
    - Lotus Notes (CroPA)
    - Salesforce (incl. Contract Management)

    If you are interested apply through this form and we will contact you


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