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Regulatory Affairs Manager

1 week ago

Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

We are looking for a new colleague to join our Regulatory department.

Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands.

As a Regulatory Affairs Manager, you are the center of product maintenance activities. You are aware of your stakeholders and understand the full value chain. You are focused, detail-oriented, and independent. In this position, you will have to juggle and structure various tasks. With both internal and external stakeholders, you do not hesitate to bring yourself and your knowledge into play and contribute to a good and open working environment.

Additionally, you will play a fundamental role in helping to shape processes and procedures to achieve timely and best practice regulatory life cycle management.

Key Responsibilities
  • Regulatory lifecycle management of a product portfolio with the purpose to successfully deliver regulatory plans in alignment with agreed business priorities.
  • Ensure that products comply with the regulations of the relevant countries/regions.
  • Preparation, review, and compilation of regulatory submissions.
  • Creation of product information (SmPC, labelling, and patient leaflets).
  • Monitoring and set timelines for product maintenance, variations, and renewal approvals.
  • Keeping up to date with national and international legislation, guidelines, and customer practices.
  • Establish and maintain relationships and lines of communication with local competent regulatory health authorities.
Requirements
  • A strong scientific background, e.g., you hold an MSc in Pharmaceutical Science, Biology, Healthcare Sciences, or similar.
  • Ideally with a minimum of 5 years of experience working with regulatory activities including Labelling, CMC, and/or other relevant aspects.
  • Proficiency in MS 365.
  • You have a proactive working approach.
  • You work well with deadlines and have excellent attention to detail.
  • You are a team player and have demonstrated ability to manage and coordinate tasks across professions including the ability to collaborate with a diverse group of internal and external stakeholders.
  • Danish or Nordic native language skills and fluency in English.

We offer an opportunity in a company with an entrepreneurial and inclusive work environment. To be a part of our ambitious growth strategy focusing on both maintaining and growing the core business and to diversify our product portfolio into new categories and regulatory regimes.

Who are we

Oresund Pharma is a Nordic-based privately owned specialty pharmaceutical company focusing on marketing value-added products in the European countries. We work with a large network of contract manufacturers, suppliers, wholesalers, and distributors, which provide us with a very dynamic, flexible, and scalable business structure. As of 2025, we will commercialize over 50 products within key therapeutic areas, such as anti-infection, intensive care, and oncology.

Need further information?

If you need further information about the job, please contact Head of Regulatory Affairs Katrine Hansen at +45 5379 6397.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Pharmaceutical Manufacturing

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