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 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

Please attach your CV in English.