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 ...