Senior Regulatory Data Manager

Application deadline: 05-Oct-2025 
Location: Gdańsk 80-309, , Poland 
Contract type: Permanent 
Job ID: 3711 

Are you an experienced Regulatory Affairs professional driven by a passion for managing and optimizing regulatory data? Do you excel in leading strategic activities and driving improvements in data management systems? If so, we have an exciting opportunity for you!

Join us in creating a future legacy in medical dermatology!

Shape the LEO Pharma of tomorrow  

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years’ experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines. This role is a highly visible and strategic role that develops and delivers global strategies and tactical asset plans through co-leadership of the cross-functional Global Asset Team.

In LEO Pharma we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Your role

Reporting to the Head of Regulatory Data Management, you will join the Data & Systems team within Regulatory Business Operations & Systems.

Your goal will be to strengthen our use of data and information technology and secure Regulatory Information Management (RIM) as a key organizational capability.

Your deliverables will include:

• Defining and governing business processes for the use of regulatory data
• Leading and facilitate strategic activities and improvement initiatives
• Responsible for driving compliance with xEVMPD, IDMP and SPOR requirements
• Supporting regulatory users globally through user assistance
• Perform training as relating to data entry and maintenance.
• Managing deviations and corrective/preventive actions (CAPA) related to regulatory data.
• Extracting and analyzing data from regulatory and business systems, for the following processes: Regulatory Serialization Data and xEVMPD, and data requests prior to audits/inspections and other ad hoc data requests from stakeholders
• Serving as a subject matter expert in audits/inspections.

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:  

• Holding a graduate qualification within life science, e.g., pharmaceutical, biotechnology or a related field
• Possessing a minimum  5 years’ experience in the pharmaceutical industry, including strong experience in global Regulatory Affairs or related roles focused on data management
• Demonstrated experience in data management and governance at a global level for pharmaceuticals, including GxP-controlled data and reporting
• Exhibiting expert knowledge in XEVMPD, IDMP, SPOR, IRIS, ePI and ESMP
• Understanding IT systems used in regulatory data management, including Regulatory Information Management Systems (RIMS) and Electronic Document Management Systems (EDMS).
• Demonstrating excellent oral and written communication skills in English
• Bringing an analytic, systematic, and structured mindset, with a strong interest in data and complex process, as well as a solution-oriented approach

Contact and application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV explaining why you are interested in this position.

Top of Form

For more information, please contact Jette Bruun Wessel, Regulatory Data Manager, at +454033932

We look forward to receiving your application. Screening and interviewing will be done on an ongoing basis during the applicant period.

Your new team

You will be a part of a highly skilled and specialized regulatory data management team, including close daily collaboration and contact with a central data entry team of 10 colleagues at our regulatory outsourcing partner. We value a strong team spirit, working in a flexible and informal environment and a supportive and humorous atmosphere.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us on our journey Beyond the Skin. Apply today!

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