Global Labelling Professional for Regulatory Affairs at AJ Vaccines

We are seeking a Global Labelling Professional to join our Labelling team, where you will support the labelling activities in our Regulatory department.

We save lives worldwide; Would you like to join us?
At AJ Vaccines, our Regulatory Labelling Unit plays a crucial role in ensuring GMP-compliant packaging materials. As a Global Labelling Professional, you will be involved in updating packaging materials based on regulatory intelligence while contributing to cross-departmental knowledge sharing to ensure the compliant and timely delivery of packaging materials. Our unit is founded on high standards, but we are always striving to improve and optimize our work processes.

If you’re passionate about making a meaningful impact, this could be the role for you. We’re seeking candidates with hands-on experience in labelling who are enthusiastic about taking on a variety of tasks.

Team responsibilities and ambitions
The Labelling Unit currently consists of two dedicated employees responsible for AJ Vaccines’ labelling tasks. Their primary focus includes updating packaging materials to meet current requirements, developing graphics using Adobe software, and ensuring compliance with both regulatory and manufacturing standards.

In this role, you will become an essential part of AJ Vaccines and our Regulatory team. Our team collaboration is built on mutual trust and respect for each other’s competencies and opinions, with commitment to adhere to current legislation and continuous learning and development.

As part of the unit, you will actively contribute to daily operations, where collaboration and knowledge sharing are integral to our work culture. You will also be closely integrated into the broader Regulatory Affairs department. We are a motivated and dedicated team, offering a professional work environment that values humor, social interaction, and a positive spirit.

Your work tasks
Our primary focus is on ensuring compliant artwork and mock-ups for cartons, leaflets, labels and other printed material. This function is performed in collaboration with the rest of the Labelling Unit and colleagues within departments such as Regulatory Affairs, Serialisation, Inspection & Packaging, QA, QC, Sales and Procurement.

As part of the team, you will:

• Update packaging material according to current templates.
• Participate in graphic development of artwork using Adobe software (Acrobat Professional, Illustrator, In-Design).
• Prepare, update, and approve registration and sales specifications.
• Engage in direct contact with partners and stakeholders globally.
• Prepare and update SOPs and work instructions.
• Maintain and acquire new knowledge regarding Danish and international legislation & guidelines for medicinal packaging as well as act proactive on new requirements.
• Participate in ad-hoc projects and continuous development and management of processes and systems.

Who are you?
We expect you to have experience in graphic design and development. Additionally, you will be responsible for staying updated on regulatory intelligence and new developments within the labelling field.

Deadlines are set on a weekly basis, making it essential for you to approach tasks in a structured and organized manner to maintain a clear overview. Attention to detail is critical in your daily work, particularly when proofreading artwork for print. Additionally, you must be fluent in both Danish and English, with strong communication skills in both written and verbal formats.

Additional skills needed:

• Knowledge of the Pharmaceutical industry and the importance of GxP.
• Understand technical drawings (e.g. diecuts), design manuals.
• Knowledge about artwork demands for primary and secondary packaging materials (e.g. labels, leaflets, cartons).
• Experienced Adobe software user (Illustrator and InDesign).
• Experienced Microsoft Office user.
• Experience with proofreading and electronic text comparison.
• Preferably experience with FMD requirements (Serialisation/Tracelink).

We offer
You will handle a wide variety of tasks within labelling and be part of a unit that is continuously evolving. The Labelling Unit is part of the Regulatory Affairs department, which consists of approximately 20 colleagues. Additionally, you will collaborate with a diverse group of dedicated and skilled professionals across AJ Vaccines, where professional sparring is an integral aspect of our work culture.

At AJ Vaccines, we prioritize both professional growth and work-life balance. We provide competitive benefits packages and foster an informal and flexible work environment, including options for remote work.

Would you like to know more?
If you have any questions or need further information, please contact Hans-Henrik Kristensen, Head of Regulatory Affairs, Medical Affairs and Scientific Communication on tel. +45 2920 3336 or via e-mail [email protected].

Interested?
If you recognize yourself in the role as Global Labelling Professional at AJ Vaccines, please apply online at your earliest convenience as we will screen candidates and initiate interviews on an ongoing basis.

At AJ Vaccines, we are committed to an inclusive recruitment process, ensuring equal opportunities for all applicants. Consequently, we kindly request that you refrain from including a photo in your CV.

We look forward to hearing from you!