Senior Specialist - Information Management and Data Quality

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.