Regulatory Officer

Psi Cro; Teletrabalho; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A leading Contract Research Organization in São Paulo seeks a candidate for regulatory submissions in clinical studies. This home-based position requires communication with regulatory authorities and management of project documentation. Candidates should possess a college degree and proficiency in English and Portuguese, with Spanish as an advantage. Excellent communication and problem-solving skills are essential. Join a company that values its people and offers opportunities for growth.

Qualificações

• Full working proficiency in English and Portuguese.
• Ability to learn, plan, and work in a dynamic team environment.
• Spanish is a plus.

Responsabilidades

• Communicate with regulatory authorities and ethics committees.
• 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.

Conhecimentos

Full working proficiency in English

Full working proficiency in Portuguese

Communication skills

Collaboration skills

Problem-solving skills

Formação académica

College / University degree or equivalent

Descrição da oferta de emprego

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.