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Regulatory Affairs Manager - Buenos Aires, Argentina - HELM AG
Encontrado en: Talent AR C2 - hace 1 día
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
