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Regulatory Affairs Senior Associate

hace 3 meses


Valencia, España Archer Daniels Midland Company A tiempo completo

.Job DescriptionThis is a fixed term/temporary position for 1 year.The Regulatory Affairs Associate leverages the clearance of raw materials, new product developments, registrations, renewals and variations of the products in the market and works in conjunction with the RSA H&W team to assess and ensure timely and accurate submission of regulatory documents.The Associate has a strategic and operative responsibility for executing all regulatory interactions and initiatives in relation to the H&W portfolio at EU manufacturing sites.The position could be located in UK, Spain, Netherlands or Denmark.Leverage global regulatory compliance of the H&W portfolio by owning the assessments of permissibility and suitability in UK, EU and US and coordinate the assessments with regional SMEs outside the EU to unlock key markets according to the commercial strategy.Own the assessment and approval of the steps that require regulatory input and are related to innovation and/or permissibility of the H&W portfolio.Leverage the operational model of the Regulatory Compliance team by ensuring that ingredients and products are assessed to ensure regulatory compliance throughout the whole life cycle and the documents shared to customers for regulatory purposes are current and available to all RSA team members.Liaising with clients, key account managers and colleagues (regulatory and other departments) to determine priority regulatory requirements in line with department and company goals. Communicate regularly with key account managers and other internal stakeholders to provide updates by interpreting, and communicating status of relevant KPIs using relevant tools (such as SalesForce and Hopper).Own the preparation, review and submission of regulatory dossiers for the H&W portfolio in EU and ensures accuracy, completeness and compliance with regulatory requirements thorough collaboration with internal SMEs and external experts outside the EU.Leverage regulatory feedback on topics related to claims and marketing materials in EU (in collaboration with Regulatory Scientific Affairs team) and coordinating the inputs from regional SMEs.According to the metrics and KPIs established by H&W and RSA, leverage the tool maintenance, trending of data and root cause analysis of KPIs.Keep abreast of regulatory requirements, guidelines and industry best practices related to H&W ingredients and make strategic recommendations to management as risks and opportunities arise.In conjunction with relevant RSA colleagues, develops and ensures maintenance of regulatory controlled documents (SOPs, Work Instructions, RSA statements and guidelines) according to the Document Management System standards.Carrying out any work which the company may from time to time deem necessary.Skills & Education & ExperienceAbility to manage multiple projects and prioritise workload.Strong problem-solving and decision-making skills