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 Bucharest, Romania
Your role:
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
- Communicate with regulatory authorities, 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 in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experience
- Prior experience with clinical trial submissions, including submission in EU Clinical Trial Information System as per EU CT Regulation
- Full working proficiency in English; French, Spanish and/or Portuguese are 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 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.
