Senior Manager/Director of Regulatory Affairs

Leading regulatory team of 2 Regulatory Associates Management of registration procedures to obtain registrations for generic medicines in line with local legislation Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases Translations of SPCs, leaflets and labelling from English to Spanish and vice versa Reviewing approved product information in post-registration/production phase Planning coordinating and supervising all activities needed for obtaining marketing authorizations Communication with local authorities Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agency Working closely with Regulatory affairs, Pharmacovigilance and QA headquarters and reporting to them We value candidates with: University degree in Pharmaceutical Sciences, Chemistry, Medicine, Vet medicine, Biology Minimum 3 years of experience in registrations (knowledge of local and international regulatory procedures and relevant legislation, knowledge of price and reimbursement procedure, working with local authorities, some experiences in pharmacovigilance) Fluent English and Spanish A person who is team oriented, accurate and good with details, self-initiative, organized and efficient, able to meet deadlines and has an honest, transparent attitude and communication #J-18808-Ljbffr