Internship Regulatory Affairs

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7imyh3

ppThe role has primary responsibility for supporting all local regulatory affairs workflow including preparation of dossiers and applications for new registration and maintain existing products life-cycle as well as applying the pharmacovigilance policy under the supervision by line Manager.
/ppSupport RA and QA team in: /pulliPreparation of dossiers and applications to register new products and maintain existing products life- cycle /liliPreparation of parallel import applications for national and central import procedures.
/liliSupporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
/liliSubmission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions) /liliArtwork revision process, i.e. requesting, proof reading, approval and implementation of artwork /liliClose cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective.
/liliMaintain and coordinate various local databases.




/liliClose contact with headquarters RA department to prioritize the new procedures and upcoming changes.
/liliSupport to Tender Dept. for qualitative related documentation.
/liliMaintenance of RA/QA internal databases and product master data /liliSupport with PQC and MI /li /ulh3The person /h3ulliAt least 6 months 1-year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority /liliKnowledge of pharmaceutical law and the required documentation for pharmaceutical product /liliAn understanding of the drug registration and reimbursement procedures /liliStrong analytical skills /liliBeing well organized and flexible /liliExcellent knowledge of MS Office, especially Excel /liliFluent English (B2 is minimum) /li /ulh3Clearly define any essential or desirable /h3ulliQualifications: pharmacy, biotechnology, biology, chemistry or similar.
/liliCertifications or accreditations: Master concerning Regulatory Affairs and PR could be a plus /li /ulpThose listed as essential will form part of the key criteria for selecting candidates for the role.
/p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7imyh3