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.
Your role
- Prepare clinical trial documents for Regulatory and Ethics submissions
- Communicate with regulatory authorities and support communication with ethics committees, project teams and vendors on regulatory-related matters
- Review translations of essential documents subject to clinical trial submission
- 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
- College/University degree or an equivalent combination of education, training and experience
- Prior experience with clinical trial submissions to ANVISA in Brazil
- Prior experience with regulatory activities for clinical trials
- Full working proficiency in English and Portuguese, Spanish is a plus
- Proficiency in MS Office applications
- Detail-oriented
- Ability to learn, plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
We offer:
- Excellent and flexible working conditions
- Extensive training and friendly, collegial team
- Competitive salary and benefits package
- Opportunities for personal and professional growth
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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