Regulatory Officer

PSI CRO AG · Milan, Italy · full-time · Hybrid · 12 days ago

Sign up to apply
Your first one is free
Posted October 02, 2026 · Read from PSI CRO
Why a CV for this job?

94% of employers say their filters drop qualified candidates whose CV does not match the ad's exact criteria (Harvard Business School, 2021).

  • They see what they asked for, first. Your experience that matches the ad leads, in the ad's own words, so someone skimming finds it in seconds.
  • It gets past the software. Many larger employers use software that ranks CVs by how closely they match the ad, often before anyone reads them.
  • In the language of the ad. An ad written in Spanish gets a CV in Spanish, even when yours is in Portuguese.
  • Your facts, nothing invented. Your own experience, reordered and reworded. What the ad wants and your CV does not show is listed for you to add, only if it is true. You check it before you send it.
See an example

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:

  • Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR)
  • Prepare and coordinate CTR Part II submission packages for Italy
  • Communicate with regulatory authorities, 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

Qualifications

  • Scientific University degree or an equivalent combination of education, training and experience
  • Previous experience with CTR Part II submissions for Italy is mandatory
  • Full working proficiency in English and Italian
  • 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

Base salary range: €36,000 – €46,000 gross annual salary.

Actual compensation: The salary offered within the stated range will depend on objective, job-related criteria, including demonstrated competencies, qualifications, and skills relevant to the position.

Additional compensation: bonus, incentive plans, and other benefits may apply.

Employer
PSI CRO AG
Location
Milan, Italy · Hybrid
Contract
full-time