Senior Packaging Compliance Analyst

Cari; København; Hybrid; DKK 582,000 - 800,000; Full time

Job summary

Lundbeck seeks a (Senior) Packaging Compliance Analyst to manage Packaging Change Requests in SAP and support artwork approval for leaflets and cartons. You will review regulatory completeness, coordinate with stakeholders, and ensure changes are implemented accurately and on time to keep medicines available to patients.

You will join the PCM team in Valby, Copenhagen, collaborating with Packaging Compliance & Master Data, Supply Chain and external partners.

Qualifications

• Experience with regulated processes, documentation, change control, packaging operations or quality/regulatory activities; experience in the pharmaceutical industry.
• Confidence with IT systems and databases; SAP and Regulatory Information Management System (RIMS) experience is an advantage.
• Interest in AI and digitalization with a mindset to explore how new technologies can improve processes and efficiency.

Responsibilities

• Evaluate and administer Packaging Change Requests (PCRs) in SAP.
• Support final technical approval of packaging artwork (leaflets and cartons).
• Review requests for regulatory completeness and quality; coordinate clarifications with stakeholders.

Skills

Regulatory processes experience

RIMS familiarity

SAP experience

AI/digitalization interest

English communication

Education

Life sciences/pharmacy/quality/supply chain related education

Job description

PCR Regulatory Affairs Professional – Packaging Change Requests and Artwork Approval

Do you combine a strong quality mindset with an interest in regulatory processes and digital workflows? You could be our next colleague helping ensure that packaging changes are implemented accurately and on time.

Your new role

As a (Senior) Packaging Compliance Analyst in Packaging Change Management (PCM), you will evaluate and administer Packaging Change Requests (PCRs) in SAP and support the final technical approval of packaging artwork, including leaflets and cartons. You will review incoming requests for regulatory completeness and quality, coordinate clarifications with stakeholders and verify that completed artwork meets the agreed requirements. Your work will help ensure timely and compliant implementation of changes so our medicines remain available to patients.

You will collaborate with colleagues in Packaging Compliance & Master Data, Supply Chain, Lundbeck Regulatory Affairs and external regulatory partners. Depending on your experience, you may also take a leading role in handling complex cases and improving processes.

Your future team

You will join Packaging Change Management (PCM), a small team of two people including you. This means you will have real ownership of your work, close daily collaboration and the opportunity to influence how we work. We value knowledge sharing, practical problem-solving and supporting each other when priorities change.

The PCM team is part of the wider PCM & MD (Master Data) team, which consists of nine employees in total and is organized within the PC & MD department. As Master Data Coordinator, you will report to the Manager of PCM & MD. Our culture is informal, dedicated and collaborative, and we also make time to have fun together.

The position is based in Valby, Copenhagen.

What you bring to the team

You are structured, service-minded and detail-oriented. You enjoy operational work, take responsibility for delivering accurate results and can balance independent decision-making with close stakeholder collaboration. We welcome different professional backgrounds and value relevant experience alongside formal education.

• A relevant education in life sciences, pharmacy, science, quality, supply chain or a comparable field – or equivalent relevant professional experience.
• Experience with regulated processes, documentation, change control, packaging operations or quality/regulatory activities; experience in the pharmaceutical industry.
• Confidence working with IT systems and databases, and the ability to learn structured workflows; SAP and Regulatory Information Management System (RIMS) experience is an advantage.
• An interest in AI and digitalization, with a curious mindset and the willingness to explore how new technologies can support process improvements, efficiency and smarter ways of working.
• Strong English communication skills, a collaborative approach and the ability to prioritize accurately under changing deadlines.

For a senior-level appointment, we would particularly value demonstrated ownership of complex Packaging change cases, regulatory experience, stakeholder coordination and continuous process improvement.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at lundbeck/global/about-us/our-commitment/diversity-and-inclusion.

Annual base salary range: 582 000 - 799 700DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

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Our contact: If you have questions, Manager PCM & MD Marianne Hjulgaard, [phone]

#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.