Regulatory Officer

2 settimane fa

Milano, Italia PSI CRO A tempo pieno

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.

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