Regulatory Compliance Specialist
3 tygodni temu
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novo Nordisk. The ideal candidate will have a strong background in regulatory affairs, excellent analytical skills, and the ability to work independently and as part of a team.
Responsibilities
- Prepare and submit regulatory documentation for new drug applications, post-marketing variations, and renewal applications to maintain marketing authorization of medicinal products.
- Translate and verify product information of medicinal products and medical devices.
- Perform proofreading of labeling items and verify promotional materials to ensure regulatory affairs compliance.
- Monitor and interpret current and changing pharmaceutical legislation and guidelines.
- Build and maintain good relationships with internal and external stakeholders.
- Archive regulatory affairs documentation and cooperate with and support the team within various regulatory affairs tasks and initiatives.
Requirements
- University degree, preferably within pharmacy, biology, chemistry, or a similar field.
- Minimum 2 years' experience in regulatory affairs.
- Analytical skills and attention to details.
- Ability to work independently and as part of a team.
- Fluency in English (written and spoken), while proficiency in local language.
About the Department
The Regulatory Affairs and Pharmacovigilance Team at Novo Nordisk is responsible for all medicinal products and medical devices available in Poland. The team is an integrated part of the Clinical, Medical, and Regulatory Department in Novo Nordisk Poland.
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