Internship Regulatory Affairs

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ik1j6

The 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.

Si assicuri di leggere attentamente le informazioni relative a questa occasione prima di inviare la sua candidatura.

Support RA and QA team in:

Preparation of dossiers and applications to register new products and maintain existing products life- cycle

Preparation of parallel import applications for national and central import procedures.

Supporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.

Submission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions)

Artwork revision process, i.e. requesting, proof reading, approval and implementation of artwork

Close cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective.

Maintain and coordinate various local databases.





Close contact with headquarters RA department to prioritize the new procedures and upcoming changes.

Support to Tender Dept. for qualitative related documentation.

Maintenance of RA/QA internal databases and product master data

Support with PQC and MI The person

At least 6 months 1-year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority

Knowledge of pharmaceutical law and the required documentation for pharmaceutical product An understanding of the drug registration and reimbursement procedures

Strong analytical skills

Being well organized and flexible

Excellent knowledge of MS Office, especially Excel

Fluent English (B2 is minimum)

Clearly define any essential or desirable

Qualifications: pharmacy, biotechnology, biology, chemistry or similar. xkiyazw

Certifications or accreditations: Master concerning Regulatory Affairs and P&R; could be a plus

Those listed as essential will form part of the key criteria for selecting candidates for the role.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ik1j6