Regulatory Submissions Publisher, Regulatory Affairs

Regulatory Submissions Publisher – Regulatory Affairs

Our 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 a Publisher to compile and manage our Regulatory Submissions within Regulatory Business Operations.

Regulatory Business Operations 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, the area is responsible for oversight of Lundbecks outsourced setup for regulatory affairs in affiliates and is responsible for all major information and documentation systems within Regulatory Affairs including the regulatory central archive and global library services.

Regulatory Business Operations is part of Regulatory Affairs. The position is based in Lundbeck’s headquarters in Valby (Copenhagen, Denmark) and the department consists of 22 highly experienced employees.

Your job and key responsibilities

As Regulatory Submission Publisher your main areas of responsibility will be:

• 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

You will co-operate with colleagues in Regulatory Affairs 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.

We offer a great workplace that is based on a flat organizational structure, and 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 professional qualifications:

• Experience with electronic document management systems, publishing tools
• 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 Regulatory Senior Scientist Mie Gøde Andersen on +45 30833775 or Senior Director, Martin Damm Olling on +45 30833632. Your application and CV should not be sent via email.

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

Your application

Please click on the link below to apply for the job. Applications must be received no later than 20th October 2019.