Regulatory Manager

.Melt Group selects a Regulatory Manager for a world leader in the development, manufacture and marketing of plant protection products. Company in the agro-industrial sector with 40 years of experience, offers the opportunity to be part of an international project in full expansion.Primary responsibilities:Keeping up to date with local and EU legislation, guidelines and practicesPreparing and submitting New Drug Applications (CTD) through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures (MAA)Maintenance of Marketing Authorization Applications (Variations and Renewals) abiding to post approval commitments, as well as handling of withdrawals and transfers of Marketing AuthorizationsReviewing of artworks and promotional material to ensure regulatory complianceAdaptation and translation of Product Information (SmPC, labelling & PIL) in compliance with the EU and local legislationSupporting pricing and reimbursement activitiesRegistration of medical devices to the National/European database and preparation/maintenance of technical dossier for CE markProviding regulatory intelligence to our clients by reviewing and evaluating marketing information, regulations, guidelines, procedures etcLiaising closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and our customersQualifications:University degree in life sciences, pharmacology or chemistryAt least 3 years of previous demonstrated experience in the regulatory fieldExcellent command (written and verbal) of English language and proficient knowledge of medical terminologyIT literacy (MS Windows, MS Office, Internet Use)Solid understanding of the drug development process, pharmaceutical legislation and scientific mattersAbility to interact professionally with customers and work effectively within a teamStrong strategic thinking, analytical and problem-solving skillsExcellent organizational, prioritizing and communication skillsAbility to manage multiple and varied tasks with attention to detailEffective time management to ensure project deadlines are metAbility to work independently with regular oversight#J-18808-Ljbffr