OverviewProfessional | Permanent | Full-time | HybridIf you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.What The Job Looks LikeEach day you\'ll enjoy a variety of challenges, such as:Delivering high-quality regulatory information management services for Grünenthal, including:RIM Product Championship (functional expertise, change management, training, and adoption of functionalities)RIM Process Management (harmonized, effective, and continuously improved business processes)RIM Data Management (effective, compliant, and aligned data management processes & standards)RIM Lifecycle Management (continuous development of RIMS platforms and adjacent technologies together with IT based on business needs)RIM Operations (high-quality regulatory operation services, including submission publishing)Leading the evolution and prioritization of the GRA digital roadmap in close alignment with R&D Digital Transformation Office and ITDriving the development of Regulatory Data Management & Governance capabilities aligned with R&D data strategy & governanceEnabling regulatory data analytics capabilities to maximize data valueLeading integration of RIMS with cross-functional systems and manages complex data landscapesDefining and executing Grünenthal’s regulatory data strategy to ensure compliance with evolving global regulations (e.g. IDMP, ESMP, eCTD 4.0)Leading vendor selection, performance management, and external partnerships for GRA digital solutions and operationsDriving operational efficiency, resource optimization, and budget management for RIM servicesMonitoring digital regulatory trends to ensure global readiness for upcoming requirementsRepresenting Grünenthal in external industry forums and engages external experts as neededWhat You\'ll Bring To The TableTo make the most of this role and truly thrive, you should have:University degree in science, technology, or equivalent experience10+ years of experience in regulatory information management within the pharmaceutical industryStrong knowledge of RIM processes across development and marketed products (EU & US required; LATAM a plus)In-depth understanding of relevant regulatory standards and regulations (e.g. IDMP, xEVMPD, eCTD, ESMP)5+ years of hands-on experience with Veeva Vault RIMS and its business processesExperience with multiple RIM technologies and digital trends in Global Regulatory AffairsGlobal regulatory experience with a focus on EU and USProven leadership and people development experience, driving high-performing teamsSolid experience in budget, vendor, and contract managementStrong project, people, change, and stakeholder management skillsExcellent communication, negotiation, and presentation skillsStrategic mindset with the ability to translate long-term vision into actionable goalsAbility to work effectively in a matrix organizationExcellent business English skills
#J-18808-Ljbffr