Internship Regulatory Affairs

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

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.

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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. xysqume
- 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.

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