Polish-Speaking Regulatory Affairs Specialist - EU Trials

Worldwide Clinical Trials; Warszawa; Remote; PLN 90,000 - 130,000; Full time

Job summary

Worldwide Clinical Trials in Warsaw seeks a Regulatory Affairs professional to lead submissions and ensure compliance with EU-CTR across Poland. You will partner with SAR colleagues, oversee document reviews, and guide junior staff through regulatory timelines. A strong Polish background and CRO experience are essential.

Fluent Polish is mandatory; English is a plus. Degree in a life science field and at least three years of CRO regulatory experience are required, with a proactive, collaborative

Qualifications

• Degree in medical, biological, physical, health, pharmacy or related science.
• Minimum three years of CRO regulatory experience.
• Strong regulatory process experience for Poland under EU-CTR.
• Fluency in Polish; working knowledge of English.

Responsibilities

• Plan, organize, compile, progress and submit regulatory submissions on time.
• May review translation of documents like applications, synopses, ICFs and labels.
• Provide local QC of submission dossiers prior to dispatch when required.
• Communicate submission status and plans to SAR Lead and project teams.
• Identify risks and propose mitigation strategies.
• Build professional relationships to expedite submissions and approvals.
• Maintain country-specific patient information sheets and labeling text.
• Keep Country Intelligence Pages up to date.
• Ensure compliance with SOPs, ICH GCP and country regulations.
• Monitor regulatory changes and update the team accordingly.
• Advise on regulatory strategies and interpret new legislation.

Skills

Organizational skills

Planning skills

Communication skills

Team collaboration

Multitasking

MS Office proficiency

Digital literacy

Education

Degree in medical/biological/health/pharmacy

Job description

Worldwide Clinical Trials in Warsaw seeks a Regulatory Affairs professional to lead submissions and ensure compliance with EU-CTR across Poland. You will partner with SAR colleagues, oversee document reviews, and guide junior staff through regulatory timelines. A strong Polish background and CRO experience are essential.

Fluent Polish is mandatory; English is a plus. Degree in a life science field and at least three years of CRO regulatory experience are required, with a proactive, collaborative