Regulatory Affairs Specialist (RA Specialist)

Essential Duties and Responsibilities:

• Prepare, review, and submit Clinical Trial Applications (CTA) in compliance with EU Clinical Trials Regulation (EU CTR, Regulation (EU) 536/2014) and
• Local regulatory requirements.Coordinate regulatory submissions via Clinical Trials Information System (CTIS) for new and ongoing clinical trials.
• Manage Part I & Part II submissions, ensuring compliance with EU and local regulations.
• Liaise with European Medicines Agency (EMA), Local regulatory authority, and Ethics Committees to ensure smooth approval processes.
• Ensure compliance with EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) for clinical investigations involving medical devices.
• Oversee submission and approval of clinical investigation applications for medical devices to regulatory authorities and Ethics Committees in the country and across the EU.
• Monitor regulatory changes and provide guidance to internal teams on EU & Country clinical trial and medical device regulatory requirements.

Experience Requirements:

• 2–5 years of experience in Regulatory Affairs related to clinical trials in the EU.
• Strong knowledge of EU Clinical Trials Regulation (EU CTR, Regulation (EU) 536/2014) and its implementation via Clinical Trials Information System (CTIS).
• Strong knowledge of EU Medical Device Regulation (MDR, Regulation (EU) 2017/745)
• Familiarity with Good Clinical Practice (GCP), ICH guidelines, and Polish regulatory requirements for clinical trial submissions.
• Hands-on experience preparing and submitting Clinical Trial Applications (CTA) to Local regulatory authorities and local Ethics Committees.
• Experience coordinating with Competent Authorities (CAs) in the country and across the EU.
• Knowledge of submission requirements for Part I & Part II under the EU CTR.
• Familiarity with IMP (Investigational Medicinal Product) Dossier (IMPD), Investigator’s Brochure (IB), Informed Consent Forms (ICF), and safety reporting requirements.
• Prior experience with regulatory intelligence tracking, gap analyses, and compliance monitoring.

Education Requirements:

• A degree or postgraduate qualification in life sciences, medical sciences, finance, business administration or similar;
• Postgraduate certification in Regulatory Affairs (e.g., RAPS, TOPRA, or equivalent EU-based programs) is a plus.
• Advanced coursework in Medical Device Regulation (MDR), Drug Development, Clinical Trials, or GxP compliance is a plus.

• English level is B2 and higher (upper intermediate and higher).
• Excellent verbal and written communication skills.
• Excellent knowledge of ICH GCP and national regulations related to clinical trials.
• Computer competence, at least MS Office.