About this role
Regulatory Affairs Specialist - Czechia - Remote
Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis. May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc. Where required provide local QC of submission dossiers prior to dispatch. Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions. Identify risks and generate mitigation strategies. When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers. Maintain country specific patient information sheet and consent form customization text. Maintain country specific drug labeling information. Maintain Country Intelligence Pages. Be familiar with and comply with SOPs, ICH GCP and applicable regulations. Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database. Advise the SAR project team about appropriate regulatory strategies. Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements. Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department. Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives.
What you will bring to the role Strong organizational and management skills Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills Self-motivated learning about current regulatory processes and intelligence Excellent written and verbal communication skills to clearly and concisely present information Team-oriented work style; seeks and gives guidance to others Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment Excellent ability to handle multiple tasks in a fast-paced and changing environment Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint Aptitude for contemporary digital systems is helpful
Your experience Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science Minimum three year of experience in clinical research, in site activation and/or regulatory-related function within a CRO Candidates must have strong experience in the regulatory process in Czechia, specifically under the EU-CTR, to be considered for this role Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations Fluency in the Czech language is a mandatory requirement; working knowledge of English
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