Medicon Village

Regulatory Affairs Specialist

Nordic Regulatory Associate Specialist

 

Do you have solid experience in Regulatory Affairs within the Nordic pharmaceutical industry?
In this role, you will be responsible for managing RA work in the Nordics, with support from and in partnership with, Regulatory Managers in the Nordics with accountability for QA and PV. Also involved in promotional compliance work and GDPR with the global privacy office.

Our International Pharma Science Center (IPC) in Denmark – Part of Ferring Pharmaceuticals
Ferring Pharmaceuticals is a global biopharmaceutical leader in reproductive medicine, maternal health, with key areas also within gastroenterology and urology. By joining our International Pharma Science Center (IPC) in Kastrup, you become part of Ferring’s global network—collaborating across functions in a state-of-the-art waterfront building with stunning views of Sweden and easy access to Copenhagen Airport. You’ll work on-site with 600 highly skilled colleagues in an international, dynamic, and collaborative environment

As the Regulatory Affairs Specialist, you will be part of a dedicated team of three Regulatory experts working within the Nordics Cluster (Denmark, Finland, Iceland, Norway and Sweden), reporting to the Head of RQS – Nordics.
This is an on-site position, working at our Kastrup site

In this role, you will have responsibilities across the following areas.

  • Lead Regulatory Affairs activities as the Nordic Subject Matter Expert, including maintenance of Marketing Authorizations, preparation and submission of variations, lifecycle management, and coordination with Global and Nordic Regulatory colleagues
  • Maintain regulatory systems and documentation, including product information, regulatory databases (e.g., DKMAnet, Farmalogg, LiiV, VnrExtranet), Ferring electronic files, and implement changes.
  • Ensure Nordic compliance through maintenance of local and regional SOPs in line with corporate policies and EU/EEA legislation.
  • Support Quality Assurance activities across the Nordic markets.
  • Support Pharmacovigilance processes by receiving, processing, reporting, and archiving safety information.
  • Work with promotional compliance and GDPR

To ensure comprehensive oversight of regulatory and compliance requirements, you have extensive Regulatory Affairs experience across multiple Nordic countries.

You need to have:

  • 5+ years’ experience in pharmaceutical industry
  • Strong expertise in Regulatory Affairs
  • Experience and knowledge also in Pharmacovigilance, Quality Assurance, and promotional compliance
  • Current understanding of regulatory requirements, legal obligations, compliance requirements, guidelines on industry interactions with healthcare practitioners, and the healthcare environment, for all Nordics countries

Additional capabilities required, include:

  • Collaborating effectively with cross‑functional teams as well as regional and global stakeholders.
  • Delivering clear, confident, and well‑structured presentations.
  • Navigating ambiguity and organizational change with agility, applying creative and practical solutions to emerging challenges.
  • Demonstrating strong digital proficiency, including advanced use of MS Office and Teams.
  • Communicating fluently in both spoken and written English, as well as in at least one Nordic language

Become a part of Ferring – apply now
If our mission and your vision are aligned, apply via this link Regulatory Associate Specialist and include a short motivation in your CV.

Please note that applications are reviewed continuously, and we close the process when we find the right match.

We are unable to offer relocation assistance for this position. Candidates must be located in the Øresund region.

Read more at ferring.com

Location: Denmark M&S