Professional | Permanent | Full-time | Hybrid If 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 like Each day you'll enjoy a variety of challenges, such as: <ul type="disc"> <li style="font-size:12.0pt">Delivering high-quality regulatory information management services for Grünenthal, including: <ul> <li style="list-style-type:none"> <ul type="circle"> <li style="font-size:12.0pt">RIM Product Championship (functional expertise, change management, training, and adoption of functionalities)</li> <li style="font-size:12.0pt">RIM Process Management (harmonized, effective, and continuously improved business processes)</li> <li style="font-size:12.0pt">RIM Data Management (effective, compliant, and aligned data management processes & standards)</li> <li style="font-size:12.0pt">RIM Lifecycle Management (continuous development of RIMS platforms and adjacent technologies together with IT based on business needs)</li> <li style="font-size:12.0pt">RIM Operations (high-quality regulatory operation services, including submission publishing)</li> </ul> </li> </ul> </li> <li style="font-size:12.0pt">Leading the evolution and prioritization of the GRA digital roadmap in close alignment with R&D Digital Transformation Office and IT</li> <li style="font-size:12.0pt">Driving the development of Regulatory Data Management & Governance capabilities aligned with R&D data strategy & governance</li> <li style="font-size:12.0pt">Enabling regulatory data analytics capabilities to maximize data value</li> <li style="font-size:12.0pt">Leading integration of RIMS with cross-functional systems and manages complex data landscapes</li> <li style="font-size:12.0pt">Defining and executing Grünenthal’s regulatory data strategy to ensure compliance with evolving global regulations (e.g. IDMP, ESMP, eCTD 4.0)</li> <li style="font-size:12.0pt">Leading vendor selection, performance management, and external partnerships for GRA digital solutions and operations</li> <li style="font-size:12.0pt">Driving operational efficiency, resource optimization, and budget management for RIM services</li> <li style="font-size:12.0pt">Monitoring digital regulatory trends to ensure global readiness for upcoming requirements</li> <li style="font-size:12.0pt">Representing Grünenthal in external industry forums and engages external experts as needed</li> </ul> What you'll bring to the table To make the most of this role and truly thrive, you should have: <ul type="disc"> <li style="font-size:12.0pt">University degree in science, technology, or equivalent experience</li> <li style="font-size:12.0pt">10+ years of experience in regulatory information management within the pharmaceutical industry</li> <li style="font-size:12.0pt">Strong knowledge of RIM processes across development and marketed products (EU & US required; LATAM a plus)</li> <li style="font-size:12.0pt">In-depth understanding of relevant regulatory standards and regulations (e.g. IDMP, xEVMPD, eCTD, ESMP)</li> <li style="font-size:12.0pt">5+ years of hands-on experience with Veeva Vault RIMS and its business processes</li> <li style="font-size:12.0pt">Experience with multiple RIM technologies and digital trends in Global Regulatory Affairs</li> <li style="font-size:12.0pt">Global regulatory experience with a focus on EU and US</li> <li style="font-size:12.0pt">Proven leadership and people development experience, driving high-performing teams</li> <li style="font-size:12.0pt">Solid experience in budget, vendor, and contract management</li> <li style="font-size:12.0pt">Strong project, people, change, and stakeholder management skills</li> <li style="font-size:12.0pt">Excellent communication, negotiation, and presentation skills</li> <li style="font-size:12.0pt">Strategic mindset with the ability to translate long-term vision into actionable goals</li> <li style="font-size:12.0pt">Ability to work effectively in a matrix organization</li> <li style="font-size:12.0pt">Excellent business English skills</li> </ul><h2 style="text-align:center">______________________________________</h2> <table style="height:200.0px;width:681.0px" border="0" cellspacing="1" cellpadding="1" align="center"> <tbody> <tr> <td><img style="width:180.0px;float:right" src="https://rmkcdn.successfactors.com/1d9a1869/0704b898-3f48-42cd-820a-c.jpg"></td> <td style="padding-left:10.0px;width:400.0px">"At this moment, we are in an exciting time of change, modernizing our RIM landscape. Join us to become part of the adventure!" Silke Thömmes, the Hiring Manager</td> </tr> </tbody> </table>

Head Regulatory Information Management (m/f/d) (Various Locations, AT, BE, DE, DK, ES, FR, GB, IE, IT, NL, PT) @ Grünenthal GmbH

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