Lundbeck L

Regulatory Submissions Publisher with Team Lead duties - Regulatory Data & Submission Management (BB-A1DD0)

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Description:
Regulatory Submissions Publisher with Team Lead duties - Regulatory Data & Submission Management



Requistion ID: 1622



Location:

Copenhagen, Hovedstaden, DK



Date: 02-Feb-2021



**Regulatory Submissions Publisher with Team Lead duties – Regulatory Data & Submission Management.**



Lundbeck’s passion links to our purpose about restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative treatments, we improve the lives of people living with brain diseases. Your dedication is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.



**Description**



_We are looking for an experienced Publisher to compile and manage our Regulatory Submissions within Regulatory Data & Submission Management. The experienced Publisher will in addition act as team lead with the responsibility to prioritize and coordinate team deliverables._



_Regulatory Data & Submission Management is responsible for key operational activities in connection with compilation and submission of marketing authorisation applications worldwide, as well as regulatory data management, and implementation of labelling and manufacturing changes in the production area._



_Furthermore, Regulatory Data & Submission Management is also responsible for system ownership and administration of business critical systems for regulatory data management._



_Regulatory Data & Submission Management is part of Regulatory Affairs, Medical Documentation and R&D Quality._



_The position is based in Lundbeck’s headquarters in Valby (Copenhagen, Denmark) and the department consists of 10 highly experienced employees._



**Your job and key responsibilities**



_As Regulatory Submission Publisher with team lead responsibilities your main areas of responsibility will be:_



+ _Lead, prioritize delegate and follow-up on team deliverables in collaboration with Senior Manager_

+ _Global operational activities related to compilation and publishing of marketing applications (initial application, variations, renewals, PSUR etc.), including:_

+ _QC and clean-up of documentation for regulatory submissions_

+ _Compilation of regulatory documents_

+ _Providing guidance on standards and technical requirements in relation to publishing_

+ _Participating in cross-organizational submission teams_

+ _System deputy responsible for Lundbeck publishing system (Liguent InSight moving to Lorenz docuBridge)_

+ Operations, maintenance and change management of publishing system



_You will co-operate with colleagues in Regulatory Affairs, Medical Documentation and R&D Quality globally and colleagues throughout the Lundbeck Value Chain._



_The job can, at times, be fast paced and the tasks are often associated with tight deadlines._



**We offer**



We offer you the opportunity to be part of a dynamic team and work in a truly global environment with exciting activities and an open working atmosphere.



Lundbeck offers a great workplace that is based on a flat structure, forming a



collaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.



**Qualifications**



_Our preferred candidate has the following personal and professional qualifications:_



+ _Solid experience in the field of publishing_

+ _Experience with coordination and coaching of teams_

+ _Experience with publishing tools, electronic document management systems_

+ _Experience from working within Regulatory Affairs, Regulatory Processes and Operations is an advantage_

+ _Proficient in working with IT systems and databases_

+ _Service minded, structured and detail-oriented_

+ _Flexible and thrive in a fast-paced environment with frequent tight deadlines_

+ _Analytical, goal oriented and strong finisher_

+ _Fluent in English_



**Further information**



For further information, please contact Senior Manager Angelina Gindeberg on +45 30 83 22 92.Your application and CV should not be sent via email.



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



**Your application**



Please click on the apply button. Applications must be received no later than 26 February 2021.



Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.



Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.



Read more at www.lundbeck.com/global/about-us/progress-in-mind



Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).



For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.

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