Polish Regulatory Affairs Specialist – Submissions

Worldwide Clinical Trials d.o.o.; Polska; Hybrid; PLN 120,000 - 190,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to lead submissions under EU-CTR in Poland. You will coordinate translation and QC of dossiers, manage regulatory strategies, and ensure compliance with ICH GCP and local regulations. Fluency in Polish and English is required, with 3+ years in CRO regulatory roles.

You will liaise with SAR colleagues, maintain country-specific docs, and mentor junior staff while supporting business development and contract negotiations.

Qualifications

• Degree in a medical/biological/health/pharmacy or related science
• Minimum 3 years in clinical research, site activation or regulatory functions within a CRO
• Strong regulatory process experience in Poland under EU-CTR
• Good knowledge of ICH GCP and country regulations
• Fluency in Polish is mandatory; working knowledge of English

Responsibilities

• Plan, organize, compile, progress, track and submit regulatory submissions
• Coordinate translation review of submission documents (application, synopsis, ICF, labels)
• Provide local QC of submission dossiers prior to dispatch
• Communicate status and plans to SAR Lead and project teams
• Identify risks and mitigation strategies
• Foster relationships to expedite submissions/approvals
• Maintain country-specific patient information sheets and drug labeling information
• Keep Country Intelligence Pages and regulatory intelligence databases up to date
• Advise SAR team on regulatory strategies and interpretation of new legislation
• Review documentation to ensure compliance with ICH GCP and country requirements

Skills

Organizational skills

Planning and project management

Communication (written and verbal)

Teamwork

Interpersonal skills

Multitasking

MS Office proficiency

Digital systems aptitude

Regulatory mindset

Education

Science degree (medical/biological/health/pharmacy)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to lead submissions under EU-CTR in Poland. You will coordinate translation and QC of dossiers, manage regulatory strategies, and ensure compliance with ICH GCP and local regulations. Fluency in Polish and English is required, with 3+ years in CRO regulatory roles.

You will liaise with SAR colleagues, maintain country-specific docs, and mentor junior staff while supporting business development and contract negotiations.