Regulatory Scientist - Regulatory Dossier Management

Regulatory Scientist – Regulatory Dossier Management

We are looking for a Regulatory colleague to join us and to take part in the journey of restoring brain health. You will be part of an organisation where we stand at the centre of it all, from the earliest stages of drug development all the way through life cycle management.

Your new role – why is this a great opportunity?
You will be responsible for coordinating and leading the execution of the global regulatory strategies with a high degree of complexity, working on development project as well as coordinating regulatory opportunities and life-cycle management activities. You will represent Regulatory Dossier Management in a regulatory team comprised of your global and local regulatory colleagues to deliver on the business strategy. Your responsibilities will be to prepare/contribute to Clinical Trial Applications, initial Marketing Applications, line extension and coordination of global maintenance activities. Furthermore, you will represent regulatory in cross functional teams and provide regulatory expert knowledge, maintain strong collaboration and communication with other key functional areas.

Your future team
The position is placed in the Department of Regulatory Dossier Management in Lundbeck headquarters in Copenhagen (DK). We are accountable for proactively execute on the global regulatory strategies of Lundbeck’s portfolio which means planning and coordinating regulatory tasks for the very first studies in humans and follow them through marketing authorization and life-cycle management opportunities. We are a large team of 18 people with a good vibe who support each other and are keen to learn more and develop.

What you bring to the team
We expect you to have:

• university credentials in a relevant life science or medical discipline, preferably with a few years’ experience working in regulatory affairs
• a good understanding of pharmaceutical guidelines/legislation and awareness of the global regulatory environment.

How your colleagues would describe you
As our new colleague we think you have good interpersonal skills including excellent communication, messaging, and presentation skills. Foremost you should have the ability to work structured, independently, and effectively across functions and geographies.

Our promise to you
Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization 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 you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include 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.

If you have questions or want to hear more, please feel free to contact Louise Nisted, Manager in Regulatory Dossier Management, +45 30 83 36 74. Applications must be received by July 14th, 2024.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and 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

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#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.

About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.