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.