Macure Group is expanding, and we are looking for a Senior Regulatory Publisher & Submission Manager to join our vibrant company. This is an exciting opportunity to shape regulatory processes in a fast-growing company and play a key role in the implementation of our new Submission Publishing Tool. If you thrive in a dynamic environment and want to make a real impact, we’d love to hear from you!

Your Responsibilities

You will report to the Head of Regulatory Affairs and take on a hybrid role covering Regulatory Publishing, Submission Management, and Regulatory Affairs. Your expertise will help us optimize our regulatory processes and ensure smooth submission workflows.

Key responsibilities include:

• Regulatory Publishing: Compiling, formatting and validating regulatory submissions in eCTD
• System Implementation & Process Optimization:
  • Playing a key role in the implementation of our new Publishing Tool—your experience and insights will help shape how we use and optimize the system.
  • Establishing best practices for digital regulatory processes in a scalable and cost-effective way.
  • Identifying opportunities to streamline workflows and drive efficiency within Regulatory Affairs.
• SOP Development & Maintenance: Writing and updating Standard Operating Procedures (SOPs) to ensure regulatory compliance and operational excellence.
• Regulatory Affairs: Supporting submission processes for National, MRP, and DCP procedures, regulatory lifecycle management, and interactions with CMOs, external partners, and health authorities.

Why This Role is Unique

Unlike larger pharmaceutical companies, at Macure you won’t just follow pre-defined processes – you will help shape them! This role is ideal for someone who enjoys hands-on involvement in building and improving regulatory systems and workflows. If you have experience in implementing or optimizing an EDMS system, your expertise will be highly valued as we move towards a more digitalized and streamlined regulatory function.

The position is in our Regulatory Affairs Team in Copenhagen, Denmark or Malta and we are open for discussing a part time position.

YOUR PROFILE:

To thrive in this role, you should have a proactive mindset, an eye for efficiency improvements, and a passion for regulatory processes. We are looking for someone with:

• A master’s degree in Life Science (Pharmacy or equivalent).
• Strong experience in Regulatory Publishing and Submission Management within the pharmaceutical industry.
• Knowledge of eCTD publishing, regulatory submission workflows, and digital document management.
• Ideally, experience in implementing or working with an EDMS system—your input will help us successfully integrate our new publishing tool.
• Experience in Regulatory Affairs, including regulatory lifecycle management and submissions.
• Strong project management skills and the ability to meet strict deadlines in a fast-paced environment.
• A solution-oriented and hands-on approach—you enjoy improving processes and optimizing regulatory workflows.
• Fluency in English (a Scandinavian language is a plus).

Why Join Macure Group?
Macure Pharma is an international specialty pharma company focusing on mature, niche hospital products. We market a diverse portfolio of established pharmaceuticals and our own niche generics, primarily in the UK and Europe.

We offer:

• A unique chance to influence regulatory processes and system implementation.
• A high degree of ownership over your projects and responsibilities.
• An informal and dynamic work environment with great colleagues.
• Opportunities for professional development in a company that values innovation and efficiency.

APPLICATION AND CONTACT

For more information, feel free to contact HR Manager, Anne Grue Larsen at +45 6020 1716.

We review applications continuously, so please submit yours in English as soon as possible to job@Macurepharma.com.