Regulatory Affairs Sr. Associate/Manager… at Eli Lilly · Herlev

Regulatory Affairs Sr. Associate/Manager Denmark & Iceland, Location: Denmark, Herlev 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 delivering results together. Key Responsibilities Support Global Regulatory Affairs applications to obtain and maintain marketing authorizations in the EEA via Centralized and Mutual Recognition Procedures. Act as the primary interface with the local regulatory agency. Ensure national Product Information complies with local regulatory requirements and global labeling procedures, implemented within designated timelines. Create, update, and approve printed packaging materials in collaboration with Nordic regulatory colleagues for shared Nordic packs. Communicate relevant regulatory information to internal stakeholders and represent the team in Nordic and local Brand Teams. Lead and perform activities related to Risk Minimization Plans. Monitor, interpret, and implement relevant national legislation and regulations. Manage and maintain regulatory documentation and tracking systems, ensuring records are accurate, current, and continuously up to date; support affiliate inspections, audits, and assessments as required. Attend external symposia and conferences to sustain and develop professional expertise. Required Qualifications Master's degree in pharmaceutical sciences, a related scientific discipline, or a healthcare field. Proven experience in an affiliate regulatory affairs role in the Nordics, with hands-on exposure to EU Centralized and Mutual Recognition Procedures. Experience covering multiple Nordic countries is an advantage. Fluent in Danish at native speaker level — written and spoken — including professional medical terminology. Professional proficiency in English, including medical terminology. About You You are a collaborative professional who genuinely enjoys working with others, bringing a self-driven approach and a strong sense of ownership. You are comfortable navigating a regulated environment and take a thoughtful, consistent approach to compliance. Specifically, you: Enjoy working across borders and appreciate diversity, actively contributing to a culture of trust and mutual respect. Work efficiently in virtual settings with international colleagues. Are well-organized, structured, and detail-oriented, with strong prioritization skills and the ability to meet deadlines. Navigate complex situations through problem-solving and critical thinking, and adapt readily when priorities shift. Bring solid IT skills and a curious, open approach to new technologies. Thrive in a flexible working environment that balances office presence with working from home. How to Apply Start date is flexible and will be agreed with the selected candidate. Applications are reviewed on a rolling basis until the position is filled. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLillyUKandIreland