Regulatory Affairs Manager

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!