[Hiring] Regulatory Affairs Specialist @Worldwide Clinical Trials

Role Description

The Regulatory Affairs department plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team:

• Leads submissions to regulatory authorities
• Coordinates with ethics committees across EMEA, Asia Pacific, and Latin America
• Ensures compliance with evolving regulations
• Drives the development and approval of innovative medical products
• Supports business development efforts
• Offers strategic guidance on contract negotiations
• Mentors junior staff
• Reviews key documentation for global regulatory standards
• Keeps all stakeholders informed throughout the submission process

As a member of the team, you will:

• Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
• Act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels, etc.
• Provide local QC of submission dossiers prior to dispatch where required
• Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
• Identify risks and generate mitigation strategies
• 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
• 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

Qualifications

• 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

Requirements

• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
• Minimum three years of experience in clinical research, in site activation and/or regulatory-related function within a CRO
• Strong experience in the regulatory process in Czechia, specifically under the EU-CTR
• 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

Benefits

• Equal employment opportunities to all employees and applicants
• Commitment to creating exceptional employee experiences
• Inclusive environment that encourages collaboration and creativity