Global Regulatory Submission Project Manager

Are you motivated by orchestrating complex regulatory submissions that bring new treatments to patients living with brain diseases? As Regulatory Submission Project Manager, you will play a pivotal role in driving global submission for Lundbeck’s high priority project and ensure timely and high-quality regulatory submissions and approvals that align with Lundbeck’s business strategy.Your new role This is a high-impact role, in which you will have the responsibility to lead global new drug submission preparation, which includes cross-functional coordination with stakeholders across value chain e.g. regulatory, clinical, CMC and commercial functions.As a chair of submission core team, you will ensure transparency, efficiency, proactive regulatory risk assessment and management as well as upward communication of submission milestones.You will be expected to be proactive toward stakeholders within and beyond cross-functional submission teams and to advance the submission preparation by leading toward decisions, evaluation of scenarios and taking calculated risks.You will work in a close collaboration with the Global Regulatory Strategy Lead and be a backbone of global new drug submission by bridging the regulatory strategy and tactics with the operational delivery.This is a fantastic opportunity for someone who enjoys working in a dynamic, global environment where collaboration, structure, and innovation meet for the benefit of patients and Lundbeck as an enterprise.Moreover, you will also be expected to proactively contribute to strengthening the capabilities and competences of the Global Regulatory Strategy function by proactively sharing knowledge, building culture of inclusion and support, participating in internal improvement projects and department activities.This is a temporary position with a fixed term of two years.Your future teamIn the Global Regulatory Strategy function, we are progressing Lundbeck’s development projects and further developing strategic brands. We do that by driving innovative regulatory strategies via combining regulatory proficiency with scientific insights, patients’ focus, solid business understanding and matrix leadership.The Global Regulatory Strategy area consists of 3 teams: Regulatory Strategy Leads; Regulatory Science & Policy and Regulatory CMC. The position is in the Global Regulatory Strategy Leads team and is placed in Valby, Denmark.What You Bring To The TeamTo be qualified for this role, you need:University credentials in life science or medical discipline, project management certification is an advantageExperience as a project manager with executing global regulatory submissions for new drugsInnovative mindset combined with solid matrix leadership skills and ability to influence on all levels of organizationAdvanced communication skills in written and spoken English.Our promise to you Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.Apply nowCan you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.If you have questions please contact Magdalena Jayatissa, VP Head of Global Regulatory Strategy by majy@lundbeck.com.Applications must be received by November 30, 2025.Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).#EveryBrainInTheGameThis job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.