Specialist, Regulatory Affairs HUB DK

Abacus Medicine Group; Københavns Kommune; Presencial; DKK 600.000 - 800.000; Jornada completa

Descripción de la vacante

Abacus Medicine Group in Copenhagen is seeking a Senior Regulatory Affairs Specialist to lead dossiers for parallel trading licenses and packaging material development in our regulated environment. You will own end-to-end regulatory tasks, monitor updates, interact with health authorities, and drive continuous improvement across processes and guidelines.

The role requires a Master's or Bachelor's in Pharmacy, RA, or Life Sciences, at least two years in pharma, and English at B2 level or higher;

Formación

• In-depth knowledge of regulatory dossiers and parallel distribution procedures.
• Experience with packaging materials design, proofreading, and document control.
• Experience communicating with health authorities.
• Experience with repackaging processes and machinery.

Responsabilidades

• Prepare and submit dossiers to obtain and maintain parallel trading licenses.
• Create and maintain packaging materials, artwork files, mock-ups, and item lists.
• Proofread packaging components, application files, and item lists for accuracy.
• Manage regulatory documentation, including packaging materials and authority-approved files.
• Communicate with health authorities and external printing houses.
• Monitor regulatory updates and implement changes.
• Identify opportunities to improve processes and workflows.
• Contribute to continuous improvement initiatives and updates to WIs and guidelines.
• Take ownership and drive tasks from start to finish.

Conocimientos

Regulatory affairs

Dossier submission

Packaging materials

Attention to detail

Process improvement

Educación

Master's or Bachelor's in Pharmacy, RA, Life Sciences

Herramientas

Adobe InDesign

Adobe Illustrator

Adobe Photoshop

Braille (EULER)

Text comparison software

Descripción del empleo

Do you want to do more than simply maintain regulatory processes? Do you enjoy challenging existing ways of working, taking ownership, and finding smarter solutions? Join our Regulatory Affairs team and help us strengthen compliance, optimize processes, and ensure smooth market access in pharmaceutical parallel trade.

The opportunity

As our Senior Regulatory Affairs Specialist, you will be responsible for obtaining and maintaining parallel trading licenses and preparing packaging materials according to SOPs, WIs, and applicable guidelines.

However, this is not a role for someone who simply follows instructions.

We are looking for someone who is curious, proactive, and not afraid to challenge existing processes. Someone who sees opportunities for improvement, takes initiative, and actively contributes to making our ways of working even better.

You will be given a high degree of responsibility and the opportunity to influence both processes and standards within your area of expertise. Your work will ensure regulatory compliance, support efficient production processes, and contribute to timely market access across your assigned markets.

We Would Like You To

In this role, you will:

• Prepare and submit dossiers to acquire and maintain parallel trading licenses.
• Create and maintain packaging materials, artwork files, mock-ups, and item lists.
• Proofread packaging components, application files, and item lists to ensure accuracy.
• Manage and archive regulatory documentation, including packaging materials and authority-approved files.
• Communicate directly with health authorities and external printing houses.
• Monitor regulatory updates and implement required changes.
• Identify opportunities to improve processes, workflows, and documentation.
• Contribute to continuous improvement initiatives, training activities, and updates of working instructions and guidelines.
• Take ownership of your area and actively drive tasks from start to finish.

About You, Our New Colleague

We are looking for a detail-oriented professional who combines strong regulatory knowledge with a hands-on and solution-oriented mindset.

You enjoy working in a structured and regulated environment, but you also question how things are done and look for ways to improve them.

You are comfortable taking ownership, making decisions, and driving initiatives independently. You don't wait for someone else to solve a problem. Instead, you take the lead, involve the right stakeholders, and make things happen.

You Bring

• A Master's or Bachelor's degree in Pharmacy, Regulatory Affairs, Life Sciences, or an equivalent field.
• A minimum of two years of experience within the pharmaceutical industry.
• Professional proficiency in English (B2 level or higher).
• Experience in at least one of the following areas:
• QA or RA within the pharmaceutical industry.
• Interaction with regulatory authorities.
• Handling medicine forms and packaging materials in repackaging processes.
• Experience with repackaging processes and machinery.
• Proficiency in Adobe InDesign, Illustrator, and Photoshop, as well as knowledge of EULER (braille) and text comparison software.

• Good written and verbal communication skills in both English and the local language.

• Norwegian or Finnish fluency will be considered an advantage.
• Residence in the country where the role is based and a valid work permit.

Skills and competencies that will make you succeed

You have a solid understanding of regulatory dossiers, parallel distribution procedures, packaging material design, proofreading, and documentation management.

At The Same Time, You Are Someone Who

• Challenges the status quo.
• Identifies opportunities for improvement.
• Takes initiative instead of waiting for direction.
• Is comfortable working independently.
• Balances accuracy with efficiency.
• Enjoys creating structure and improving processes.

You understand that compliance and continuous improvement go hand in hand, and you are motivated by the opportunity to influence how things are done.

Are your interested?

We’d love to hear from you if you want to be part of an international team ensuring compliance, efficiency, and patient safety.

Our Recruitment Process

We value a transparent and efficient recruitment process.

• First interviews will be conducted online during week 38.
• Second interviews will take place in person at our office in Copenhagen during week 40.

We review applications on an ongoing basis.

Moving Healthcare. Moving You.

In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine.

But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,500 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move.