Lundbeck Copenhagen Denmark
2 weeks ago
Why should you be part of our journey?
We have a flat organization and an informal working environment with a high degree of empowerment and knowledge sharing, where we actively apply agile methodologies and mindset for increased transparency, idea sharing, prioritization and continuous optimizing our way of working.
Our regulatory science analyses and regulatory landscape oversight requires focused data mining, impact assessment and monitoring of external interdisciplinary trends / initiatives (e.
g., RWE, novel trial methodology, patient insights, digital tools) informing regulatory decisions. As part of this you will work with our other experienced regulatory science leads while also working directly with our global regulatory leads and with relevant stakeholders across R&D.
Hence this in a unique opportunity for you to work directly within the Lundbeck portfolio with the focus to accelerate the pipeline and strategic brands.
In a typical day you could be working on a... regulatory science analysis exploring the evidentiary standards for expediated regulatory pathways within a rare CNS disease, checking in with relevant R&D stakeholders to prepare an impact assessment on a key drug development guideline as well as participating in the recurrent regulatory agile standup meeting with your regulatory science colleagues to share the progress of your activities.
In Lundbeck, our commitment is embedded in our Danish heritage, our solid foundation ownership and our culture of innovation.
To us, it is essential that Lundbeck is a place where you grow and thrive both personally and professionally. We have a dedicated focus on individual and team development and nurture a growth culture.
Highlights from responsibilities
You will be at the core of how we inform our regulatory strategies and activities and hence you must be service minded, highly structured in applying analytical skills and understanding the customers need.
You will be in touch with many people throughout the organization and in that capacity be a strong ambassador for Regulatory Science & Policy.
We are looking for someone who will thrive in balancing independent detailed desk work with outgoing cross functional engagement and communication with examples of responsibility mentioned below :
Contribute, engage, and lead regulatory science activities at disease / topic level in accordance with portfolio needs
Monitor and communicate on regulatory pathways and development topics based on business priorities, e.g., expedited programs, orphan drug development, digital technologies for use in drug development, novel trial designs and disease assessment tools
Support and drive regulatory internal and external engagement in line with the global Lundbeck policy strategy, aiming to increase Lundbeck’s external impact and visibility
Drive and coordinate Lundbeck position and prepare impact analysis of key regulatory topics in drug development
Facilitate and drive knowledge-sharing and education globally and cross functionally on topics relevant to regulatory strategy and drug development
Monitor, analyze impact and communicate regulatory precedence, regulatory environment and competitor programs critical to drug development strategy in collaboration with global regulatory strategy leads
Build insight of the development projects in the pipeline to support and actively challenge regulatory strategy on overall regulatory pathways and integrated evidence generation strategies targeting optimal approval pathway, label claims and differentiation
Example on professional and / or interpersonal competencies
Our preferred candidate has most of the following personal and professional qualifications :
University credentials in a relevant life science or medical discipline with 5+ years of relevant experience in regulatory science or regulatory development strategy and / or relevant experience from employment at a Competent Authority or life science trade organization.
Successful track record in preparing regulatory science analyses and regulatory intelligence communications
Hands on experience with regulatory policy
Drug development experience within neuroscience and / or rare diseases is an advantage
In depth understanding of the regulatory framework and requirements across regions
Curious scientific mindset motivated by outgoing cross-functional collaboration and the ability to influence and interact effectively with internal and external customers
Team player with good interpersonal skills including excellent communication, messaging and presentation skills
Ability to work structured, independently, and effectively across functions and geographies and to lead and motivate regulatory sub-teams and cross-functional working groups
Our preferred candidate has profound understanding of the regulatory framework as well as hands-on experience working within Regulatory Science.
Flair for written and verbal communication and excellent spoken and written English skills
Regulatory Science Lead Copenhagen jobs
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