Regulatory Affairs Coordinator - Multiple Teams

Global Regulatory Operations | eCTD Submissions | Regulatory Systems

Pharmacosmos is seeking an experienced Regulatory Affairs Coordinator to join our Regulatory Affairs department of 21 employees. The department manages new marketing authorisation applications and the life-cycle management of human and veterinary medicinal products globally.

 The role supports global regulatory operations, including eCTD submissions, regulatory publishing, document management and life-cycle activities across international markets. Experience with Veeva RIMS is preferred and may provide the opportunity to take on implementation and post-implementation responsibilities, depending on the candidate’s background.

Your responsibilities

• Supporting global regulatory operations, including submission planning, document handling and regulatory follow-up 
• Contributing to Veeva RIMS implementation, maintenance, user support and continuous improvement, where relevant to your experience
• Preparing, compiling, technically validating and submitting regulatory dossiers in eCTD format across global markets
• Ensuring submission readiness, document quality and high-quality regulatory data
• Supporting product roll-out and life-cycle management of marketing authorisations worldwide
• Collaborating with international affiliates and partners to prepare, compile and deliver regulatory documentation packages, ensuring timely submission and follow-up of variation and other life-cycle activities
  
  

Who are you?
We imagine that you:

• Hold a relevant educational background within life sciences or a related field, combined with experience in regulatory affairs and pharmaceutical document handling
• Have hands-on experience with Veeva RIMS, preferably including implementation, key user activities or user training
• Have strong experience with the preparation, validation and submission of eCTD dossiers globally, preferably using Veeva Submission Publishing
• Have experience with regulatory publishing, submission management and document processes
• Have experience with broader regulatory activities, partner contact and international life-cycle management
• Hold a relevant educational background and have experience from the pharmaceutical industry
• Have strong IT skills and an interest in data quality, digitalisation and process improvement
  
  

Personal qualifications

• You are meticulous, systematic and detail-oriented
• You are proactive, take ownership and communicate effectively with internal and external stakeholders
• You are curious, service-minded and contribute positively to a professional and social team environment
• You are fluent in written and spoken English; Danish is considered an advantage
• You thrive in a collaborative and international environment where quality and deadlines are important
  
  

We offer you
You will join a well-established global company and play an important part in supporting regulatory operations and strengthening our eCTD submission capabilities. Depending on your experience, you may also contribute to the implementation and ongoing development of Veeva RIMS. The role offers independent responsibility, close collaboration and exposure to global regulatory activities. Employment terms are negotiated individually based on your qualifications.

The position is located in Holbæk, with a minimum requirement of working in the office three days a week after completion of training.

Application
If this sounds like the right opportunity for you, we look forward to receiving your CV and cover letter.
For questions about the position, please contact Birgitte Møller, Senior Manager of Regulatory Operations, at +45 41 64 46 65.
Submit your CV and cover letter via the “Apply” button. Application deadline: 24 October.
 
About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 650 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA.