Senior Specialist - Information Management and Data Quality
Job Description
Your Role:
As a Senior Specialist Information Management and Data Quality, you will be responsible for overseeing the data management and governance of regulatory data to ensure accuracy, consistency, and completeness across complex regulatory processes. Also working on Data framework and working with emerging technologies to enhance the efficiency of regulatory data.
In this role, you will work within a matrix organization, engaging extensively with stakeholders from Global Regulatory Affairs and other functions to promote data literacy, streamline information workflows, and embed best practices in regulatory data management. You will play a key role in enabling teams to work effectively on diverse projects by ensuring clear communication, scalable solutions, and robust data governance aligned with business priorities.
You will also lead the adoption and implementation of innovative technological solutions, such as automation and AI, to enhance the efficiency and effectiveness of regulatory operations and information management.
Who You Are:
Minimum Requirements:
- Experience: 8–14 years of work experience in a pharmaceutical environment, competent authority, or academia/R&D experience related to the role.
- Minimum 6-8 years of regulatory affairs or regulatory operations.
- Education: Degree in a Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent degree).
- Certifications like Lean Six Sigma, CDMP, PMP and others will be a strong advantage.
Maximum Requirements:
- Demonstrate strong expertise working in Pharmaceutical Regulatory Affairs and Regulatory Operations.
- In-depth knowledge of EU and international regulatory requirements related to the life cycle management of both developmental and authorized products.
- Strong understanding of regulatory workflows and document lifecycle management.
- Strong understanding of VEEVA Vault RIM Data Model and Connection with Regulatory Processes.
- Lead and contribute to Data Governance initiatives focused on regulatory data management.
- Promote data literacy and advocate for Data Governance best practices among users and stakeholders.
- Foster data literacy among users and promote Data Governance among stakeholders.
- Communicate clearly and effectively with all stakeholders to support our regulatory objectives.
- Lead the drive and implementation of innovative technology solutions to enhance regulatory processes, including automation and AI projects.
- Strong understanding of Pharmaceutical Regulatory Affairs business process.
- Hands-on experience in Regulatory Information Management tools, particularly VEEVA Vault RIM.