Associate Regulatory Affairs

5 mesi fa

Milano, Italia Amgen A tempo pieno

**HOW MIGHT YOU DEFY IMAGINATION?**

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

**ASSOCIATE REGULATORY AFFAIRS IVDR - CLINICAL**

**JOB SUMMARY**:
The **Pre-Authorization phase** involves the activities related to the maintenance of authorizations for a clinical trial (CTA) to AIFA during the transition period to the management of the same according to the new European Regulation (CTR), including evaluations and notifications of non-substantial amendments and submission of Clinical Study Reports and Activities related to the authorization of IVDR clinical trials according to the new regulation.

The **Post-Authorization** phase of products involves a number of numerous activities for the proper maintenance of the relevant Marketing Authorizations.

The person will coordinate with other people within the department itself and will follow all phases of post-authorization of products, from clinical development to obtaining authorization, to Marketing Authorization; so that he/she will have a better understanding of all the activities peculiar to this function within a pharmaceutical company.

**LIVE**

**This could be your everyday**

Let’s do this. Let’s change the world. During this program you will:

- Notification of non-substantive amendments and Clinical Study Reports, both electronically via OsSC and in paper form
- Comprehensive management of IVDR Performance Studies from a regulatory perspective
- Archiving management of the activities performed

Post-authorization phase: New AIC Applications, Line Extensions, Extension of Therapeutic Indications
- Conduct of Centralized Procedures (Translation of texts within the timeframe required by the European Procedure and preparation and updating of Artwork)
- Performance of Mutual Recognition/Decentralized procedures (Management of documentation filing to AIFA until the authorization measure is obtained and published in the Official Gazette)
- Review of promotional materials and related AIFA filing
- Management of printed materials for inclusion in UNIFARM database
- AIFA filing management for local, regional and national events

**WIN**

**Here’s what it takes to Win**
- Knowledge of Regulatory principles.
- Working with policies, procedures and SOP’s.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- Understanding of drug development.
- Knowledge of IVDR Performance studies
- Demonstrate ability to work in teams.
- Ability to understand and communicate scientific/clinical information
- Bachelor/Master Degree in Regulatory or related scientific area

**THRIVE**

**Some of the vast rewards of working here**

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

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