Regulatory Affairs Expert

6 dni temu


Warszawa, Mazovia, Polska Tomasz Rutkowski Solo Law Firm Pełny etat

**About the Role:**

We are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with all applicable regulations and guidelines.

In this position, you will be responsible for the preparation and submission of clinical trial applications (CTAs) across various countries, including EU CTR and other international submissions. Your excellent knowledge of regional/national country regulatory guidelines, GCP, and ICH standards will enable you to effectively lead projects and ensure high-quality regulatory documents.

The ideal candidate will possess a strong background in clinical research, specifically in regulatory affairs, with a minimum of 2-3 years of experience working in Poland. Experience in initial CTA submissions, sponsor-facing roles, and CTIS is highly valued. Fluency in English is required, with additional languages being an asset.

We offer a stimulating work environment, attractive advancement opportunities, and a permanent full-time position with flexible scheduling. If you thrive in a collaborative setting and have a passion for regulatory affairs, we encourage you to apply.



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