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Regulatory Strategy Lead

 
Requistion ID:  3333
Location: 

Copenhagen, Hovedstaden, DK

Date:  22-Nov-2022
 

Regulatory Strategy Leader – Regulatory Affairs

 

We are looking for an experienced global Regulatory Strategy Leader with abilities to deliver global regulatory strategies for continuous optimization of our marketed products.

 

In Regulatory Affairs, we proudly support the Lundbeck purpose about restoring brain health, so every person can be their best. In this position, you will be part of an organization, that defines the regulatory strategy and is responsible for the execution of regulatory activities for our marketed products.

 

Regulatory Affairs consists of more than 50 experienced colleagues in Lundbeck headquarters in Copenhagen (DK) and has a flat organizational structure with efficient and short decision pathways.

The position is placed in the Department of Regulatory Strategy Established Products, a small department of currently 3 skilled and committed people. We are accountable for maximizing and maintaining our marketed products in a constantly changing regulatory environment throughout the life cycle of the products.

 

Why should you be part of our journey?

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.

Together, we are creating a brighter future for people living with brain diseases. That is our promise to each other and to the world.

Lundbeck offers a great workplace that is based on a flat structure, forming a collaborative working environment based on respect and equality. We employ skilled colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.

 

Your job and key responsibilities:

You will be responsible for preparing, leading, and implementing the regulatory strategies of marketed products across the world. To accomplish this, you will represent RA in cross-functional teams with other key areas in Lundbeck, such as commercial areas, CMC, nonclinical, clinical, medical and safety.

In a typical day, your activities will range from discussing a strategy with the cross-functional team, evaluating an idea from our commercial colleague to leading a team meeting comprised of your regulatory colleagues, preparing for health authority interactions, looking into safety information from the markets with our global safety colleagues. Together with your affiliate regulatory colleagues, you will be representing Lundbeck at key health authority meetings and interactions.

This position reports to the Head of Department of Regulatory Strategy Established Products and is based in the main R&D facility in Valby, Copenhagen.

 

Example on professional and interpersonal competencies

 Our preferred candidate has the following qualifications and experience:

  • University credentials in a relevant life science or medical discipline with 5+ years’ experience in regulatory development strategy or relevant experience from employment at a Regulatory Agency.
  • Experience in preparing global regulatory development strategies.
  • Innovative mindset motivated by outgoing cross-functional collaboration and the ability to influence and interact effectively with internal and external customers.
  • Ability to work structured and effectively across functions and geographies and to lead and motivate regulatory sub-teams and cross-functional working groups.
  • Team-oriented person with good interpersonal skills including proven communication, messaging, and presentation skills.
  • Fluent in English both written and spoken.

 

Want to learn more?

For further information, please contact Ann-Lisbeth Aarup Nielsen on alpu@lundbeck.com or +45 40709939.

We are waiting for your application by the 10th of December.

Your application and CV should not be sent via email.

We also recommend that you have a look at our website, LinkedIn and Instagram.

 

Sounds interesting?

Please click on the apply button.

About Lundbeck

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best.

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn