Global Regulatory Compliance Manager

3 days ago


Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

Oresund Pharma is seeking a Regulatory Affairs Manager to lead our product registration efforts globally. As a key member of our Regulatory department, you will ensure the successful delivery of regulatory plans aligned with business priorities.

Key Responsibilities:
  • Oversee the regulatory lifecycle management of our product portfolio.
  • Ensure product compliance with regulations of relevant countries/regions.
  • Prepare, review, and compile regulatory submissions.
  • Create product information (SmPC, labelling, and patient leaflets).
  • Monitor and set timelines for product maintenance, variations, and renewal approvals.
  • Stay current with national and international legislation, guidelines, and customer practices.
  • Maintain relationships and lines of communication with local competent regulatory health authorities.
Requirements:
  • A strong scientific background, e.g., an MSc in Pharmaceutical Science, Biology, Healthcare Sciences, or similar.
  • Ideal experience includes at least 5 years of work with regulatory activities, including Labelling, CMC, and/or other relevant aspects.
  • Proficiency in MS 365.
  • A proactive working approach.
  • Ability to work well with deadlines and excellent attention to detail.
  • A team player with demonstrated ability to manage and coordinate tasks across professions, including collaboration with diverse internal and external stakeholders.
  • Danish or Nordic native language skills and fluency in English.


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