Regulatory Affairs Manager, Denmark
Location Denmark – Själland
Apply by 2026-04-24
Workplace Hybrid
Regulatory Affairs (Senior) Associate or Manager, Nordics
Primary responsibilities will be affiliate regulatory affairs activities for Denmark and Iceland, where the latter will be executed in collaboration with an Icelandic vendor, as well as initiating and coordinating printing packaging material development and revisions for the Nordic countries.
The role is based in our office in Herlev, Copenhagen. The role is expected to work from the office 2-3 days per week, with the option to work from home the remaining days.
Key Responsibilities:
- Support Global Regulatory Affairs applications to obtain and maintain marketing authorizations in the EEA via the
- Centralized and Mutual Recognition Procedures.
- Act as the primary interface with the local regulatory agency.
- Ensure that national Product Information complies with local regulatory requirements and global labeling procedures, and that updated Product Information is translated, submitted, approved, and implemented within the designated timelines.
- Create, update, and approve printed packaging materials in collaboration with your regulatory colleagues in the Nordic countries for shared Nordics packs.
- Communicate relevant regulatory information to internal stakeholders.
- Represent the team and function in the Nordic and local Brand Teams, as applicable.
- Lead and perform activities related to Risk Minimization Plans.
- Ensure appropriate monitoring, interpretation, and implementation of relevant national legislation and regulations.
- Strive for inspection and audit-readiness and participate in aligned affiliate inspections, audits, and assessments.
- Keep data in relevant tracking systems up-to-date and accurate.
- Regulatory oversight and collaboration with applicable Third Parties.
Required Qualifications:
- Master’s degree or equivalent in pharmaceutical or other relevant science or health care related field.
- Relevant prior experience from an affiliate regulatory affairs role working with the EU Centralized and Mutual Recognition procedures.
- Fluent in Danish (written and spoken), including professional knowledge of medical terminology.
- Professional knowledge of English, including medical terminology.
About the Successful Candidate:
- Enjoy working in a team and have strong collaboration skills.
- Appreciate diversity and actively contribute to a working environment of trust and mutual respect.
- Work effectively in a virtual setting with colleagues in other countries.
- Work independently, are self-driven, and proactive.
- Prioritize and allocate time efficiently to meet deadlines.
- Well-organized and structured with attention to detail.
- Manage complex situations through problem-solving and critical thinking.
- Have the flexibility to adjust to altered priorities.
- Have good relevant IT skills and a positive and curious approach to new technologies.
- Thrive in a flexible working environment, balancing office presence and working from home.
Responsible recruiter
Otto Simonsson
[email protected]
