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Product Registration Expert

2 weeks ago

Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

We are looking for a highly skilled Regulatory Affairs Manager to join our team at Oresund Pharma. As a key contributor to our Regulatory department, you will play a critical role in ensuring the compliance of our products with regulatory requirements worldwide.

Key Responsibilities:
  • Develop and maintain a product portfolio following regulatory requirements and commercial demands.
  • Ensure that products comply with the regulations of the 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 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., 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.