Experienced Regulatory Science Lead in Regulatory Science

Experienced Regulatory Science Lead in Regulatory Science & Policy

In Lundbeck we proudly serve the purpose of restoring brain health, so every person can be their best. While we progress in the field of neuroscience to develop new medicines conquering brain diseases, we contribute to this important purpose in Regulatory Science & Policy by informing the global regulatory strategies for Lundbecks portfolio of development projects and marketed products. We do that through regulatory intelligence and regulatory science analyses as well as engaging in regulatory policy topics.

As part of this quest, we are looking for an experienced colleague with hands-on regulatory policy experience who wants to drive our regulatory science and policy efforts and shape our regulatory strategies and policy engagement.

Your new role why is this a great opportunity?

As part of the job role, you will work side-by-side with our experienced regulatory science leads while also working directly with our global regulatory strategy leads and with key stakeholders across and beyond R&D. It is a great chance to work alongside dedicated colleagues who support the development of innovative treatments that improve the lives of people living with brain diseases.

We are accountable for preparing regulatory intelligence and regulatory science analyses. More so we are targeted to build our regulatory policy framework and operating model to guide our regulatory policy activities and our engagement in trade organisations.

Hence this in a unique opportunity for you to work directly with the Lundbeck development projects and particularly becoming a focal point for shaping our regulatory policy engagement on areas of relevance for Lundbeck.

In Lundbeck, our commitment is embedded in our Danish heritage, our solid foundation ownership, and our culture of focused innovation. To us, it is essential that Lundbeck is a place where you grow and thrive both personally and professionally and we have a dedicated focus on individual and team development

You are thriving in balancing independent detailed desk work with outgoing cross functional and external engagement and possess strong communication skills with examples of responsibility mentioned below:

Facilitate regulatory communications and collaborations, adhering to the global Lundbeck regulatory policy framework, and overseeing trade association initiatives to boost Lundbeck's impact and visibility with external stakeholders Build and maintain an internal network of subject matter experts to contribute to Lundbecks position and advocacy Facilitate public comment processes on draft guidelines and legislation Prepare impact assessment on new guidelines and legislation Monitor and communicate on regulatory pathways and drug development topics based on business priorities, e.g., expedited programs, orphan drug development, digital technologies, novel trial designs and clinical assessment tools Monitor, assess impact and communicate on regulatory precedence and competitor programs Prepare regulatory science activities at disease/topic level Facilitate knowledge-sharing and awareness globally and cross functionally on topics relevant to regulatory strategy, regulatory policy and drug development

Your future team

The position is placed in the Department of Regulatory Science & Policy which is closely integrated in the Global Regulatory Strategy organisation and is based in Copenhagen, Denmark. You will be part of a team of 3 highly committed employees. We target our deliverables at the core of drug development and regulatory strategy from the earliest stages of drug development all the way through life cycle. We work cross-functionally and globally with focus on our Lundbeck portfolio to inform innovative regulatory pathways.

We have a flat organization and an informal working environment with a high degree of empowerment and knowledge sharing, where we actively apply agile methodology and mindset for increased transparency, idea sharing, prioritisation and continuous optimising our way of working. We are well founded and recognised in delivering high quality regulatory science analyses and in monitoring and shaping the regulatory landscape.

What you bring to the team

You will be at the core of how we inform our regulatory strategies and drive our regulatory policy activities and hence you are customer focused, highly structured in applying analytical skills and understanding the portfolio. You will be in touch with many people throughout the organisation and in that capacity be a strong ambassador for Regulatory Science & Policy.

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 policy, regulatory science or regulatory development strategy and/or relevant experience from employment at a Competent Authority or Pharma trade organisation Profound hands-on experience with regulatory policy; monitoring, impact assessment, position preparation and communication is needed Experience as company representative in trade organisation is an advantage Experience preparing regulatory science analyses and communicating regulatory intelligence is an advantage Drug development experience within neuroscience and/or rare diseases is an advantage In depth understanding of the regulatory framework and requirements across EU and US Curious scientific mindset motivated by outgoing cross-functional collaboration and the ability to influence and interact effectively with internal and external stakeholders Team player with good interpersonal skills including good 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 Proficient in English written and verbal skills

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterised as collaborative a must to successfully bring our treatments through research and development all the way to commercialisation and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but youre 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. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

#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.

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