regulatory affairs specialist a SIENA

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siena, toscana
Infermieristica, farmacia, medicina
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For major multinational pharmaceutical company we are looking for a RA Senior Specialist.
Main activities:
- Coordinate and having responsibility for the preparation of regulatory submissions such as clinical trials applications, IND submissions and amendments,variations, renewals, support for marketing applications (International/LatAm) etc. (under the general guidance of their supervisor).
- Participate in the approval of promotional material as required and helping to resolve external medical/technical enquiries, when required (under the general guidance of their supervisor).
- Help develop and review product label texts
- Sit on designated working teams and providing regulatory input to these teams including preparation of draft position papers on regulatory issues, draft regulatory sections of project plans and to develop regulatory strategies (to be approved by their supervisor).
- Aid in the maintenance of the departmental archive of administrative and technical documentation according to internal procedure.
- Provide regulatory advice within the framework of the company’s Change Control procedure, and to support the company’s regulatory compliance personnel (to be approved by their supervisor, as relevant
-Scientific degree is preferable + 3 or 4 years specific RA experience
-Excellent knowledge of written and spoken English
-4 years work experience with Pharmaceutical Regulatory Affairs.
- Knowledge of regulatory procedures and requirements.
- Working knowledge of electronic tools/systems.
- Ability to work in an autonomous manner and manage his/her time.
- Good communication skills and culturally aware
Lingua: Inglese
I candidati ambosessi (L.903/77) sono invitati a leggere l’informativa sulla privacy (art.13, D.Lgs.196/03).