Chemistry Manufacturing Control Specialist

2 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Job

This is an exciting opportunity to join our team as a CMC Regulatory Specialist and contribute to the development of new medicines at Novo Nordisk. As a member of our team, you will work closely with stakeholders across multiple functions in a global environment to ensure compliance with regulatory requirements.

You will be responsible for leading activities for synthetic small molecule projects in late development as well as driving scientific and regulatory discussions across our portfolio. Your expertise in synthetic small molecules will be invaluable in ensuring the success of our projects.

Some of your key responsibilities will include:

  • Applying regulatory intelligence and establishing strategy for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs)
  • Submission of regulatory files and responding to questions from health authorities
  • Ensuring the preparation, review and submission of pre-meeting packages for health authority meetings as well as conducting rehearsals and participating in the meetings
  • Addressing process challenges by performing analyses and proposing new ways to support projects
  • Identifying phase appropriate regulatory risks and developing mitigation strategies
  • Performing the regulatory assessment of planned or implemented CMC changes based upon global regulatory guidelines

About Our Benefits

We offer a competitive compensation package that includes a salary, bonus and benefits. Our company also offers a range of opportunities for professional growth and development, including training programs and mentorship initiatives.

Our commitment to innovation also applies to the way we work: We embrace the hybrid workplace where you can balance working from home and the office.



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