Regulatory Affairs Senior Data Steward (m/f/d)

Regulatory Affairs Senior Data Steward (m/f/d) at Grünenthal Group. This role is in Professional | Permanent | Full-/ Part-time | Hybrid. If you’re passionate about advancing therapies and improving patient lives, this opportunity offers the chance to contribute in a state-of-the-art Research & Development environment, working on innovative medicines and data management initiatives.

• Lead or support development, implementation and maintenance of data standards and data policies in the GRA Digital Eco System.
• Ensure alignment of implemented data standards with external requirements where applicable, such as ISO IDMP standards in the EU & US.
• Lead or support implementation and maintenance of activities related to external structured data management requirements – xEVMPD, IDMP, SPOR, ESMP, etc.
• Ensure alignment of data standards with internal cross-functional systems and processes within R&D (e.g., Development, Drug Safety) and outside R&D (such as Global Operations).
• Champion data management responsibilities for the Global Regulatory Affairs Digital Eco System.
• Oversee creation, update and maintenance of master data, reference data and critical transactional data within RIMS, ensuring conformance with defined standards.
• Lead or support the implementation and maintenance of a data quality framework, data management KPIs, monitoring and reporting activities.
• Lead or support delivery of data analytics and reporting requirements from RIMS & GRA Advanced Analytics capability.
• Lead or support data transfer strategy and execution related to M&A (transfer of data, documents, submissions).
• Collaborate closely with GRA Digital Product Champions, Process Champions and IT teams to ensure alignment between data, process and technology.

• University degree in Life Sciences, Regulatory Affairs, Systems and Data Management, or Business Administration.
• Expert level understanding and 10+ years working experience with Regulatory data management, data governance and data quality initiatives.
• Deep expertise and 6+ years of experience with structured data submissions (IDMP, SPOR, xEVMPD).
• Strong understanding and working experience of regulatory data sources, interfaces with R&D, Global Operations and external systems.
• Strong understanding and working experience with Veeva Vault RIM Suite (Registrations, Submissions, Submissions Archive, Publishing).
• Veeva certified professionals preferred.
• Ability to manage multiple tasks simultaneously in a results-driven and customer-focused environment.
• Excellent communication and presentation skills in English.
• Attention to detail, can-do attitude and a positive and proactive mindset.
• Excellent team collaboration skills, with the ability to work independently when required.