Junior Regulatory Data Manager

Field of work: Regulatory & Medical

Posting Date: 12 Sept 2025

Application deadline: 05-Oct-2025
Location: Gdańsk 80-309, , Poland
Contract type: Permanent
Job ID: 3715

Are you a Junior Regulatory Affairs professional with an interest for regulatory data and systems? Do you possess the skills to drive daily operation and lead improvement initiatives related to the input and output of regulatory data from business tools and 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:

Assisting in defining and governing business processes for the use of regulatory data
Supporting regulatory users globally including handling of daily operation tasks
Performing training as relating to data entry and maintenance
Extracting and analyzing data from regulatory and business systems, for the following processes: Regulatory Serialization Data and xEVMPD ( Extended EudraVigilance Medicinal Product Dictionary), and data requests prior to audits/inspections and other ad hoc data requests from stakeholders
Responsible for compliance with xEVMPD, IDMP ( Identification of Medicinal Products) and SPOR ( Substance, Product, Organization and Referential data standards ) requirements
Providing support in audits/inspections and handling of deviations and CAPAs

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 2 years of experience from the pharmaceutical industry preferably with relevant experience from Regulatory Affairs globally or related functions with data management focus
Having Interest in data management and willingness to learn about global regulatory processes dealing with GxP controlled data and reporting.
Holding basic Knowledge of the IT landscape and systems used in regulatory data management, e.g., Regulatory Information Management Systems (RIMS) and Electronic Document Management Systems (EDMS)
Demonstrating excellent spoken/written communication skills in English
Bringing an analytic, systematic, and structured mindset, with an interest in data and complex process, and highly solution oriented

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.

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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