Lilly
Healthcare
RegulatoryAffairsSr.Associate/ManagerDenmark&Iceland
Neural analysis suggests this role is
optimal for Manager candidates.
“Regulatory Affairs Sr. Associate/Manager Denmark & Iceland at Lilly. Skills: Regulatory affairs, Marketing authorization, Compliance. Support Global Regulatory Affairs applications. Obtain marketing authorizations in EEA”
Industry & Context.
Problem-solving; Critical thinking
What They're Looking For.
Must Have
Master's degree in pharmaceutical sciences, Master's degree in a related scientific discipline, Master's degree in a healthcare field, Proven experience in affiliate regulatory affairs role, Hands-on exposure to EU Centralized Procedures, Hands-on exposure to Mutual Recognition Procedures, Fluent in Danish at native speaker level, Professional proficiency in English
Nice to Have
Experience covering multiple Nordic countries is an advantage
What You'll Do.
Support Global Regulatory Affairs applications
Obtain marketing authorizations in EEA
Maintain marketing authorizations in EEA
Act as primary interface with local regulatory agency
Ensure national Product Information complies with local requirements
Ensure national Product Information complies with global labeling
Create printed packaging materials
Update printed packaging materials
Approve printed packaging materials
Communicate regulatory information to internal stakeholders
Represent team in Nordic Brand Teams
Represent team in local Brand Teams
Lead activities related to Risk Minimization Plans
Perform activities related to Risk Minimization Plans
Monitor national legislation
Interpret national legislation
Implement national legislation
Manage regulatory documentation
Maintain regulatory documentation
Ensure records are accurate
Ensure records are current
Attend external symposia
Attend external conferences
How You'll Work.
Team & Collaboration
Collaborate with colleagues across Nordic organization; Collaborate with colleagues across global organization; Work with Nordic regulatory colleagues; Work with internal stakeholders; Work with Brand Teams
Communication Scope
Communicate regulatory information
Full Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. **Regulatory Sr. Associate / Manager, Denmark and Iceland** We have an exciting opportunity for a skilled regulatory professional to join our Nordic Regulatory Affairs team. This role offers scope to be shaped around your experience and is ideally suited to someone who sees affiliate regulatory affairs as a core part of their professional journey. If you thrive in a team, take pride in ownership, and are motivated by creating results together — with a proactive mindset and a genuine desire to grow — this position at Eli Lilly Denmark could be the perfect next step in your career. **About the Role** You will be responsible for affiliate regulatory lifecycle activities across Denmark and Iceland, spanning from initial marketing authorization and local product launch through line extensions, variations, and eventual license de-registration. Day-to-day, you will work in a dynamic international environment, collaborating both in person and virtually with colleagues across the Nordic and global organization to ensure regulatory excellence, compliance, and patient safety. The role is based at our office in Herlev, Denmark, reports to the Head of Regulatory Affairs and Patient Safety, Nordics, and offers a flexible working arrangement. **About the Team** You will join an engaged and inclusive Nordic team with colleagues across the Nordic countries. We operate as one team, built on collaboration, shared ownership, and a strong focus on
Applying for this Regulatory Affairs Sr. Associate/Manager Denmark & Iceland role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Lilly?
Real rants from real employees. Read before you apply.