Regulatory Officer

3 semanas atrás

São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro
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 submissions of clinical studies.
You will focus on facilitating the approval to start research projects for novel medicinal products, while taking a step further in your professional career.
This is a Home Based position
**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
Full working proficiency in English and Portuguese. Spanish is a plus.
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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