Regional Regulatory Affairs Manager

5 - 10 years of experience in regulatory affairs management, specifically with clinical trials submission and LifeCycle within the EU region, in non EU is a plus, demonstrating in-depth knowledge of EU Clinical Trials Regulation (EU CTR), GCP, and other relevant regulations., Know-how in regulatory requirements for complete lifecycle of a product, from initial development through preclinical and clinical trials, to post-marketing surveillance and product withdrawal if necessary in the country or region. Proven experience managing clinical trial submissions, interactions with regulatory authorities, and compliance activities. Knowledge of regulations governing the design, conduct, and reporting of clinical trials with ability to interpret complex regulatory information and provide strategic guidance., Ability to execute assigned task independently, strong project management skills & proactive communication approach, driving process excellence, mitigate business risks & ensure compliance as well as effectively design, prioritize, keep information confidential, escalate issues, manage time effectively, gain alignment and successfully execute processes., Gain visibility in duplicating or contradicting processes to eliminate or adapt them as needed to increase quality & speed execution., Ability to focus on implementing measurements and taking corrective actions on processes management. Ability to make process design decisions conditionally, with the understanding that they may or may not work out as you continue toward a final solution. Knowing when to change and when to stick with previous decisions., Ability to interact effectively with all levels of management, acquire know-how, emphasize team learning & plan apprenticeship with experienced colleagues., To create clear, easy-to-follow work schedules with specific requirements and deadlines to maintain high standards with optimal efficiency., Be comfortable, understand how to assess & evaluate the impact of change within a team/organization. Effectively prioritizes competing tasks in a fast-paced and dynamic environment., Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success. Know-how on project budget management. High proficiency in English.

sharing the costs of sports activities, private medical care, sharing the costs of foreign language classes, sharing the costs of professional training & courses, life insurance, remote work opportunities, flexible working time, fruits, integration events, mobile phone available for private use, corporate car available for private use, computer available for private use, retirement pension plan, corporate library, no dress code, video games at work, coffee / tea, drinks, parking space for employees, leisure zone, extra social benefits, pre-paid cards, holiday funds, employee referral program, charity initiatives, extra leave