Senior Regulatory Affairs Specialist

We are hiring for a Senior Regulatory Affairs Specialist for our site in Boxmeer As a Senior Specialist, you will play a pivotal role in enabling data-driven transformation within the Global Regulatory Affairs (GRA) organization. This role is ideal for a strategic and analytical professional with deep expertise in regulatory processes, digital enablement, and continuous improvement. You will drive with us cross-functional collaboration, and harness data to enable proactive, strategic, efficient, and compliant regulatory operations across the globe. Moreover, you will be involved in optimization and implementation of Business Processes, ranging from creation of process flows, writing, editing and reviewing of Standard Operation Procedures and other procedural documentation. Key Responsibilities: 1. Data-Driven Insights & Analytics Design, implement, and maintain regulatory performance dashboards, scorecards, and reporting tools. Analyze operational, quality, and compliance data to identify trends, inefficiencies, and improvement opportunities. Generate business insights by integrating and interpreting data from multiple sources—including regulatory systems such as Veeva Vault, quality databases, and other platforms such as e.g. SAP—to support strategic decisions and resource prioritization. 2. Regulatory Process Optimization & Excellence Identify opportunities for automation, digital tool adoption, and advanced analytics in regulatory operations. Support global initiatives to standardize, simplify, and optimize regulatory processes and documentation workflows. Develop and manage technical and/or procedural documentation including Policies, Global Standards, Standard Operating Procedures, Work Instructions and Job Aids, and in choosing the most optimal structure of documentation types to support operational excellence. Create and maintain training materials where appropriate. Provide training, presentations, and communication on relevant systems use and alignment when business processes vary. 3. Regulatory Intelligence & Oversight Obtain, maintain, and communicate to Global Regulatory Affairs country-specific regulatory requirements by working closely with regional regulatory teams and leveraging internal and external intelligence sources. Support knowledge-sharing mechanisms and tools that enable global teams to access reliable, current regulatory requirements and filing strategies. 4. Change Management & Organizational Transformation Act as a change agent to drive digital transformation and foster a culture of data-informed decision-making. Facilitate workshops, retrospectives such as After Action Reviews, and cross-functional collaboration sessions to co-create solutions. Provide business expertise and impact assessments for rollouts of new systems, tools, and ways of working, ensuring alignment with global strategies and stakeholder needs. 5. Stakeholder Engagement & Communication Collaborate closely with global and regional regulatory teams, IT, Quality, R&D, and Commercial functions to align initiatives and accelerate implementation. Prepare and deliver executive-level updates on progress, risks, and key performance indicators. Promote transparency, ownership, and regulatory excellence across all levels of the organization. Qualifications: Education: Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Science, Business, or a related discipline. Experience: 5–8 years of experience in Regulatory Affairs, Regulatory Operations, or relevant business transformation roles within the pharmaceutical, biotech, or animal health industries. Proven experience with global change initiatives featuring a strong data and analytics component. Experience working with data visualization tools (e.g. Power BI, Tableau) and strong proficiency in Excel; knowledge of data analysis tools or coding languages (e.g. Python, R) is an asset. Skills & Competencies: Good understanding of global and local regulatory frameworks, submission processes, and compliance requirements. Strong analytical skills with the ability to extract insights from complex datasets. Excellent communication, stakeholder management, and facilitation skills. Strategic mindset and high adaptability in complex, matrixed environments. Curiosity, critical thinking, and a drive to innovate and improve. Preferred Qualifications: Experience with Regulatory Information Management Systems (RIMS), preferably Veeva Vault. Familiarity with global regulatory intelligence tools or databases for country-specific regulatory requirements. Certifications in Lean Six Sigma, Change Management, or Agile methodologies. This is a temporary position, more information will be provided upon application

Location: Boxmeer, North Brabant, NL

Posted Date: 7/19/2025