Regulatory Officer

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.

Home-based in Colombia.

**Your role**:

- 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;
- Deliver regulatory training to project teams;
- Assist with feasibility research and business development requests.

**Qualifications**:

- College/University degree or an equivalent combination of education, training and experience;
- Prior experience with clinical trial submissions in Colombia;
- Full working proficiency in English and Spanish;
- 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.