Senior Regulatory Officer

6 days ago

Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 900,000 - 1,200,000 per year

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Join our team of experts in regulatory 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 Prague, the Czech Republic

Your role:

  • Prepare and oversee the preparation of clinical trial submission
  • Acts as a Regulatory Lead in complex clinical trials and programs of clinical trials: coordination of CTIS submission, shared responsibility for developing global and country-level submission strategy
  • Primary responsibility for discussing submission strategy with sponsors
  • Identifying regulatory risks and working on mitigation plans
  • Managing consistency of approaches and regulatory processes across multiple trials in programs of clinical trials
  • 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

Qualifications

  • College/University degree or an equivalent combination of education, training and experience
  • A minimum of 5 year's experience with clinical trial submissions in the Czech Republic (experience in Slovakia is an advantage)
  • Extensive experience with Clinical Trial Information System (CTIS)
  • Full working proficiency in Czech (or Slovak) and English
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

Additional Information

Start your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:

  • Excellent and flexible working conditions.
  • A unique combination of team collaboration and independent work.
  • Competitive salary and benefits package.

If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.

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