Stage Regulatory Affairs

Career Category

Job Description

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.

GRAD INTERN – Regulatory Affairs

LIVE

This could be your everyday

• Let’s do this. Let’s change the world. During this program as a member of the Regulatory Affairs team, you will report to the Regulatory Affairs Manager and oversee the management of post-authorization phases for Centralized and Mutual Recognition/Decentralized procedures for our product portfolio. This includes:
• For Centralized Procedures: translation and review of texts within the timeframes required by the European Procedure and preparation and updating of artworks;
• For Mutual Recognition/Decentralized Procedures: management of authorization steps, from the submission of documentation to AIFA to the obtaining of the authorization decree and its publication in the Official Gazette.

Alongside this project, other activities carried out within the Regulatory Affairs Department may be added to give the opportunity to better understand the peculiar activities of this function within a pharmaceutical company. In particular, the activities listed below could give an insight into what it means to operate within the RA department of a pharmaceutical company:

• review of promotional materials, preparation of package for submission to AIFA, management of materials and archiving also for Farmindustria Audit purposes;
• product maintenance activities (AIC Decrees and publication in the Official Gazette, Bollini, Artworks);
• updating the FARMASTAMPATI portal following authorization of variations;
• bilinguism (management of printed materials for insertion into the UNIFARM database);
• daily legislative monitor (AIFA, Farmindustria, Guritel/Official Gazette);
• other AIFA obligations and various and eventual activities arising from daily activities;
• activities in the pre-authorization phase: applications for obtaining authorization for clinical trials (IVDR Performance studies) and related activities.

For the candidate, it will be an opportunity to learn a working methodology in the Regulatory Affairs Department and develop skills and experience in a leading biotechnology company.

WIN

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. We seek a candidate with these qualifications.

• University degree in scientific area such as Pharmacy/Medicinal chemistry/Biotechnology
• Preview or on-going Regulatory Master
• Good problem-solving skills, proactivity and attitude to team work.
• Fluency in English, both written and oral
• Timeline management
• Organizational skills

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.

APPLY NOW

for an internship that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.