Regulatory Affairs Manager

Key Responsibilities: 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 Planning coordinating and supervising all activities needed for obtaining marketing authorizations Communication with local authorities We value candidates with: University degree in Pharmaceutical ...