Regulatory Affairs Professional - Packaging Change Requests and Artwork Approval

Regulatory Affairs Professional – Packaging Change Requests and Artwork Approval

Join our community of specialists and take part in the journey of restoring brain health

We are looking for a new member of our packaging change request (PCR) Team. The team is part of the Regulatory Business Operations (RBO) department in R&D and is responsible for the processing, evaluation and approval of PCRs and artwork for Lundbeck’s pharmaceutical products globally.

You will be part of a focused team based in the Lundbeck HeadQuarter in Valby.



Why should you be part of our journey?

The processing and approval of changes in the PCR flow is a fundamental part of the process to convert a regulatory submission with labeling impact into an actual packaging material to make Lundbeck’s products available for our patients. This requires a high level of collaboration within the team as well as with relevant stakeholders from other cross-functional areas of the company (e.g. regulatory submission coordinators, product supply, global patient safety, local regulatory representatives).

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 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.

Highlights from responsibilities

PCRs are used for creating new packaging materials or updating existing ones, based on global regulatory approvals. The workflow is based on SAP software.  

As responsible for the evaluation of PCRs, you will:

• Check data points in SAP, RIS (regulatory information system) and artworks to ensure consistency and compliance
• Update/create PCRs in the system based on information received and in collaboration with the artwork and master data department within product supply
• Perform final assessment of Artworks to ensure compliance
• Support regulatory colleagues globally on questions related to the creation and processing of PCRs.

Example on professional and/or interpersonal competencies

To be successful in this position, you need to possess a high level of quality mindset and attention to details. We expect you to be able to operate independently and take ownership of tasks assigned to you, but as the level of complexity and criticality of each PCR can vary significantly, you must also work in very close collaboration with the team and its stakeholders. The timely and correct processing of PCRs has a direct impact on making Lundbeck’s products available to our patients.

Our preferred candidate has the following personal and professional qualifications: 

• High quality, structured and detail-oriented mindset
• High collaborative, interpersonal attitude coupled with self-driven, proactive approach
• Proficient in working with IT systems and databases
• Flexible and thrive in a fast-paced environment with frequent tight deadlines 
• Experience from working within RA/QA processes or operations is an advantage 
• Fluent in English. 

Want to learn more?

For further information, please contact Angelina Gindeberg, Sr. Manager Data&Submission Management, on AGI@lundbeck.com or +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.

Sounds interesting?

Please click on the apply button. Applications must be received no later than 31st March 2022.

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. 

Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.  

We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments 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 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion). 

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

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