Regulatory Compliance Expert

6 days ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

Job Description

Our company is seeking a Regulatory Compliance Expert to join our Emerging Technologies API Manufacturing Development (ET API MDev) team. In this role, you will be responsible for ensuring compliance with GxP guidelines and regulations, supporting management in setting the direction for the department on quality challenges and opportunities.

Responsibilities

  1. Act as a single point of contact for audits and inspections, driving planning and execution while ensuring overall inspection readiness.
  2. Drive the yearly planning of quality activities across the department, ensuring alignment with regulatory requirements.
  3. Develop and maintain a comprehensive understanding of regulatory frameworks, guiding the department's quality strategy and initiatives.

Qualifications

  • A degree in a relevant field, such as Pharmacy, Engineering, or Science, or equivalent knowledge through relevant practical experience.
  • Minimum 2 years' experience within GxP guidelines and regulations, with current legislation expertise.
  • Excellent communication and collaboration skills, with proficiency in both spoken and written English.


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