Regulatory Officer
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About the role
Hybrid Regulatory Officer role in the Milan area supporting Italy-focused clinical trial regulatory activities under the EU Clinical Trials Regulation. Responsibilities include coordinating CTR Part II submissions, communicating with authorities and project teams, reviewing translations and documentation, and supporting investigational product release. A scientific university degree or equivalent route, mandatory Italy CTR Part II experience, English and Italian proficiency, and MS Office proficiency are required. Base salary is €36,000–€46,000 gross annually, with possible additional compensation.
Key requirements
- • Scientific University degree or an equivalent combination of education, training and experience
- • Required skills: Country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR), Preparation and coordination of CTR Part II submission packages for Italy, Communication with regulatory authorities, project teams and vendors, Review of translations of essential clinical trial submission documents, Regulatory project documentation tracking, Review of documents for investigational product release to sites, MS Office applications, Communication, Collaboration, Problem-solving, Ability to learn, plan and work in a dynamic team environment
- • Required languages: English, Italian
Opportunity details
- • Workplace: Hybrid
- • Posted: Oct 2, 2026
- • Original advert language: English
Full vacancy
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See original vacancy ↗Employer’s role description
Job title: Regulatory Officer
Location: Milan, Lombardy, Italy
Employment type: Full-time
Workplace type: Hybrid
Company Description
PSI is a leading Contract Research Organization with more than 30 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.
Hybrid working arrangement in Milan area
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.
Please submit your CV in English.
Verification
- ✓ Employer verification
- ✓ Original posting located
- Last verified: Oct 5, 2026