Senior Specialist - Country Liaison, Operational Excellence

Job Description

Support, coordinate, and contribute to different and new Regulatory Affairs projects and Regulatory IT systems across the regions. Contributes to training and training documentation creation of new regulatory systems and newcomer act as SME (Subject Matter Expert) or Champion Coordinate and support Country Audit & Inspection readiness. Define/confirm regional reg. approaches for upcoming local product changes. Engage in compliance and data governance and quality initiatives, focusing on data cleansing and monitoring processes to support automation and AI. Support update management through document localization (RIMS local repository). Collaborate with cross-functional teams to define regional regulatory strategies for product changes. Serve as internal International Regulatory Affairs point of contact for TA and RQS operations. Performs a range of routine or even non-routine assignments to solve problems of low to moderate complexity that require working knowledge and experience in own job discipline. Led efforts in VV processes and regulatory requirements, focusing on compliance and data governance. Monitors and create reports on compliance with the defined data quality standards. Who You are: 6 or more years of experience in regulatory affairs field. Know-how in regulatory and understanding of regulatory affairs business processes. Ability to execute assigned task, time management skills & proactive communication approach. Drive process excellence, ensure compliance. Ability to 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 interact, acquire know-how, emphasize team learning & plan apprenticeships 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. High proficiency in English. Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.