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Junior Regulatory Affairs Consultant

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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
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