Regulatory Affairs Manager Benelux > Antwerp > Joboolo BE :
Société : Elanco Lieu : Antwerp Flanders Site source : Talent BE
Position DescriptionThe main purpose of this position is to contribute to the maintenance of existing and registration of new animal health products (veterinary medicinal products, feed additives, biocides and care products) through ensuring regulatory compliance and continuity of supply in accordance with business needs, directions and strategies in the European area with a special focus on Benelux.This role works with various Elanco departments, such as other regulatory functions, pharmacovigilance, quality, supply chain, manufacturing, business as well as with external parties like health agencies, distributors, national institutes, etc.Functions, Duties, TasksEnsure compliance with regulatory requirements (timely submission of regulatory procedures including Variations, Renewals, Referrals) for existing and upcoming portfolio (Pharmaceuticals, Vaccines, Feed-Additives, Biocides)Update of the various regulatory Information management programs ( Vault RIM/Pharao) and documentation repositories in agreement with regulatory management & internal procedures.Coordinate and/or conduct packaging development as part of ALRP responsibilities in Benelux, including release of production artwork in BLUE.Contribute to project forecast and prioritization and regulatory strategy in BeneluxProvide leadership in the coordination of Benelux issues, submissions, packaging updates and other national tasksRegulatory review and approval of promotional materials in PromoMatsMonitor regulatory environment including updates of national regulations and other European regulations/guidelines applicable locallyBuild and maintain good relationships with the Competent Authorities of Benelux countries, with a focus on established productsWork effectively, efficiently and flexibly within and across all Elanco teams and external collaborators to achieve overall Elanco registration deliverables.Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.Provide information to facilitate accurate and timely project and budget forecastsPerform other regulatory related duties/assignments, support BeNeNo Team and lead BeNeNo RegulatoryAffairs projects on a as needed basis when required by business and directed by managementMinimum Qualification (education, experience and/or training, required certifications)Advanced degree in life sciences (, veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.Good computer skills (Word, Excel, knowledge of data management)Excellent interpersonal and communication skillsStrong attention to detailGood planning and organizational skillsFluent English language and Dutch language (written and verbal)Additional PreferencesPrevious experience in hands-on working in regulatoryaffairs, ideally in a similar positionFluency in French (written and verbal) is an assetOpen-mindedness and team player Elanco AntwerpFlanders
