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Lead global regulatory strategies for late-stage development programs to ensure successful NDA/MAA submissions and commercialization. Collaborate across matrix teams to align global strategies with local registration requirements in major international markets.
Requires a university degree in life sciences or medicine, with a PhD preferred and experience in global regulatory strategies and health authority interactions. Candidates should possess strong matrix leadership skills and scientific knowledge of CNS, biologics, or rare diseases.
Regulatory Strategy Leads, focus on NDA/MAA submissions
We are looking for 2 experienced Regulatory Strategy Leads, Senior Specialist/Director, to join Lundbeck and contribute to innovative late-stage development programs focused on bringing new treatment options to patients living with neurological disorders and significant unmet medical needs.
Your new role
In this role, you will play a key part in strengthening the alignment between global regulatory strategy and local registration requirements and you may work as EU regulatory lead or as a bridge between global regional regulatory leads in Japan/China and Lundbeck headquarter. You will work in cross-functional and cross-regional settings to contribute to strategic oversight and ensure successful progression of one of Lundbeck’s late-stage development programs toward submissions and commercialization across major international markets.
Together with the Global Regulatory Strategy Lead you will contribute with your strategic regulatory expertise to shape innovative regulatory approaches and tactics. Your work will include supporting Health Authority interaction planning and contributing to clinical development strategies, assessing regulatory risks, and identifying mitigation opportunities. You will combine development experience with regulatory judgement to bring the regulator’s perspective into programme strategy and critically reviewing evidence packages, development plans, submission approaches, and key messages through the lens of regulatory expectations, scientific credibility, patient benefit, and benefit-risk assessment.
As part of the Regulatory Focus Team (RAFT), you will work in close partnership with the Global Regulatory Strategy Lead, regional regulatory leads in Japan and China, and the RA CMC Lead to progress development and registration activities, as well as plan registration-enabling interactions with health authorities. You will operate in a highly collaborative matrix environment with a variety of cross-functional stakeholders including clinical leads, biostatisticians, data scientists and medical writers, safety scientists and many other functions involved with global regulatory submissions and approvals.
We are looking for a calm, credible partner in complex and high-demand environments, able to navigate ambiguity, manage competing priorities, and remain structured and solution-focused in high-stakes regulatory and development discussions. You will be a confident collaborator and influencer across global matrix teams, able to work effectively across functions, cultures, geographies, and organisational levels, building alignment while constructively challenging thinking where needed. In addition to project responsibilities, you will be a contributor to the broader Global Regulatory Strategy function, actively strengthening capability through knowledge sharing, inclusive collaboration, internal improvement initiatives, and participation in department activities.
Your future team
In the Global Regulatory Strategy function (consisting of Global Regulatory Strategy Leads, Regulatory Science & Policy and RA CMC teams), 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. You will be part of Global Regulatory Strategy Leads team.
The position is based in Valby, Denmark. Hybrid working arrangements may be considered depending on your country of residence.
What you bring to the team
To succeed in this role, you are likely to bring:
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.
Annual base salary range:
Senior Specialist’s level: 786 000 - 1 081 300 DKK gross
Director’s level: 910 000 - 1 251 800 DKK gross.
At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.
Apply now
Can 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 Trine Oesterby, Senior Director, Global Regulatory Strategy Lead at [email protected] or Krishan Nigah, Scientific Vice President, Global Regulatory Strategy Lead at [email protected].
Applications will be reviewed ongoing and must be received by 01 Aug 2026.
Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).
#EveryBrainInTheGame
This 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.
Advancing brain health. Transforming lives.
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com
Offices: H. Lundbeck, Ottiliavej 9, Valby, Copenhagen 2500, DK
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