Junior Regulatory Affairs Consultant Rif. JSB.HR.2014.05 of 27/10/2014 JSB Solutions, a GXP consulting and IT information solutions provider for companies in the pharmaceutical and industrial sector, is looking for a Junior Regulatory Affairs Consultant. Junior Regulatory Affairs Consultant, responding to the Regulatory Affairs Manager, should have the following characteristics: Instruction:  Degree in Pharmaceutical Sciences, Chemistry, Biology or relevant disciplines  Appreciated Master in Regulatory Disciplines or in other areas pertinent with the field Years of Experience:  At least 1-2 years of experience in Regulatory Affairs Purpose of the position:  Preparation of all the necessary scientific documentation for the registration of medicinal products in accordance with the current regulations: - CTD, - DMF - Variations IA, IB, II, renewal, etc…  Revision and updating registration dossier, gap-analysis and consequent evaluation of the regulatory strategy  Regulatory Compliance Mandatory skills:  English Level: strong  Availability to travel for work in Italy or abroad  Knowledge of GMP, ICH and EU guidelines, international regulation and directives;  Problem solving;  Ability to work in team;  Very good communication skills with internal and external customers; Not mandatory but  Knowledge of GCP. appreciated skills  Knowledge of Advanced Therapies process and relative guidelines.  Knowledge of Pharmacovigilance guidelines (regulation, PSUR, etc..) Location  Firenze Start of Contract  January 2015 Type of contract  Contract to be defined on the basis of the candidate’s experience To apply: https://www.linkedin.com/jobs2/view/11798223?trk=job_nov JSB SOLUTIONS SRL IT AND COMPLIANCE SOLUTIONS Legal Office & Headquarters: Via Lorenzo Il Magnifico 10 50129 - Firenze P.IVA 05996860481 Operative Office: Viale Mentana 148 43121 - Parma Cap. Soc. € 50.000 i.v. Tel. +39.055.49.09.45 Fax: +39.055.398.05.72 [email protected] www.jsb-solutions.com 1 di 1