Regulatory Affairs Specialist

1 dzień temu


Warszawa, Mazovia, Polska Novo Nordisk Pełny etat
Job Title: Regulatory Affairs Specialist

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novo Nordisk. As a key member of our Regulatory Affairs and Pharmacovigilance Team, you will be responsible for ensuring compliance with local legislation and Standard Operation Procedures (SOPs) for our medicinal products and medical devices.

Key Responsibilities:

  • Preparing and submitting Regulatory documentation for New Drug Applications, post-marketing variations, and renewal applications to maintain Marketing Authorization.
  • Translating and verifying Product Information of medicinal products and medical devices.
  • Performing proofreading of labelling items and verifying promotional materials to ensure Regulatory Affairs compliance.
  • Monitoring and interpreting current and changing pharmaceutical legislation and guidelines.
  • Building and maintaining good relationships with internal and external stakeholders.
  • Archiving Regulatory Affairs documentation and cooperating with the team on various Regulatory Affairs tasks and initiatives.

Requirements:

  • University degree in pharmacy, biology, chemistry, or a related field.
  • Minimum 2 years of experience in Regulatory Affairs.
  • Excellent analytical skills and attention to detail.
  • Ability to work independently and as part of a team.
  • Fluency in English (written and spoken), with proficiency in local language.

About Novo Nordisk:

We are a dynamic company in an ever-changing industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.

Join our team:

At Novo Nordisk, we're committed to making a difference in the lives of patients. If you're passionate about Regulatory Affairs and want to be part of a team that's driving innovation and excellence, we'd love to hear from you.



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