Internship Drug Regulatory Affairs Bardi

Internship Drug Regulatory Affairs
Bardi
Emilia Romagna, Bardi

Internship Drug Regulatory Affairs

**-

**233213

**OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals.

Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.

Now, we are powered by 52, 000 employees globally who nurture a diverse, collaborative and inclusive culture.

We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

**THE INTERNSHIP

For our site in Fornovo San Giovanni we are looking for an intern to join the Drug Regulatory Affairs Department.

During this formative period, he/she will have the opportunity to understand the role and the importance of the function within a company that produces Active Pharmaceutical Ingredients (APIs) destined to the manufacturing of drugs for Human Pharma and Animal Health.

Furthermore, he/she will acquire skills performing transversal activities and dealing with a multinational company context.

Definitely something new to learn every day!

**We offer a 6 months internship with possibility of extension

**Tasks & what you will be learning

- Assistant in the in-time preparation, compilation and maintenance of CMC documentation for global submissions based on international pharmaceutical requirements, aligned with the corresponding GxP relevant documentation, for the global network.

- Support colleagues in coordinating the review and approval cycles for all relevant CMC submission documents among the relevant interfaces within the BI system

- Ensure regulatory compliance as well as legal and internal requirements

- Assist in providing further submission documentation including scientific documents (e. g.

statements, justifications, etc.

), DMF/CEP documentation for the drug substance in scope and contributes to responses to Health Authority questions on request.

**Requirements**:

- Master's degree in Chemistry, CTF or Pharmacy

- Master in Regulatory Affairs is a plus

- Languages: Native level of Italian and strong knowledge of English (C1)

- Good knowledge of Ms Office (especially Word and PowerPoint)

- Curious and analytical attitude, propensity for continuous improvement, innovation and teamwork

- Ability to prioritize and mental agility

**WHY BOEHRINGER INGELHEIM?

- With us, you can grow, collaborate, innovate and improve lives. _

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices.

In addition, learning and development for all employees is key, because your growth is our growth.

To learn more about what benefits could be waiting for you, please visit our Career area

**Job

- Regulatory

**Primary Location

- Europe-IT-Lombardia-Fornovo San Giovanni

**Organization

- IT-Bidachem (Italy)

**Schedule

- Full-time