Regulatory Officer Milano

Regulatory Officer
Milano
Lombardia, Milano

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.

We focus on delivering quality and on-time services across a variety of therapeutic indications.

**Job Description**:

Join our team of experts in regulatory and ethics submissions of clinical studies.

You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

Hybrid working arrangement in Milan area

**Your role**:

- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities

- Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters

- Track the regulatory project documentation flow

- Review documents to greenlight IP release to sites

- Manage safety reporting to authorities where applicable

- Deliver regulatory training to project teams

- Assist with feasibility research and business development requests

- May act as Regulatory Lead for global projects

**Qualifications**:

- Scientific University degree or an equivalent combination of education, training and experience

- Prior experience with clinical trial submissions in Italy

- Prior experience with CTIS completion will be considered a plus

- Prior global Regulatory experience is preferable

- Full working proficiency in English and Italian

- Detail-oriented

- Ability to learn, plan and work in a dynamic team environment

- Communication, collaboration, and problem-solving skills

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.