Pharmaceutical Regulatory Affairs Professional

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Role

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We are seeking a highly motivated and detail-oriented Pharmaceutical Regulatory Affairs Professional to join our team at AGC Biologics. In this role, you will be responsible for ensuring compliance with regulatory requirements and industry standards in the pharmaceutical industry.

Key Responsibilities:

  • Collaborate with colleagues within the department and stakeholders from other departments to ensure compliance is maintained at the appropriate level.
  • Handle quality documents such as deviations, change controls, CAPAs, and procedure updates.
  • Familiarize yourself with the related technical systems to manage your tasks independently.
  • Contribute to the continuous improvement of our utilities, facilities, and systems.
  • Present documentation during audits and inspections.

Your Profile:

  • A relevant technical background as an engineer or equivalent technical experience in the pharmaceutical or process industry is required.
  • Knowledge of GMP is preferable, along with experience in operations, maintenance, or project participation, and most importantly, a passion for working with quality-related documentation.
  • You are pragmatic and flexible, with a strong focus on achieving goals and a personal drive to complete tasks effectively.
  • You have a structured approach to planning and executing tasks.


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