Regulatory Affairs Pharmacovigilance Associate
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Job Location:
Prague - Czech Republic
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Are you passionate about ensuring regulatory compliance and patient safety Do you have experience in Regulatory Affairs and Pharmacovigilance If you are ready to make a difference in a dynamic and impactful role we are looking for a new RA & PV Associate to join our team in Prague. The role is a substitute for a maternity and parental leave. Read on and apply today!
The position
- As an RA & PV Associate you will play a vital role in ensuring regulatory compliance and safeguarding patient safety.
- To secure regulatory approval of new products in due time
- To maintain existing registrations and continuously update the regulatory files
- Safety reporting
Regulatory
Back-up to all regulatory activities and mandatory 2nd proof-reader for translations manuscripts RA systems
- Text translations for the Centralized Procedure products
- Preparation of local submissions: Mutual Recognition Decentralized and National Procedure local new products variations renewals PSURs etc. and ordering and submissions of samples active/reference substances
- Local language labelling preparation (new and updated): translation proof- reading approval of proofs in system and preparation of PMI
- Veeva Vault RIM handling (updates in Vault RIM as per valid SOPs)
- RA administrative tasks
Safety
- Acting as safety responsible person back-up in the affiliate for safety reporting of marketed products
- Responsible for timely safety reporting to Health Authority and to Global Safety
- Medical literature monitoring
- Safety administrative tasks
Qualifications
We are looking for a candidate with the following qualifications:
- Min. bachelors degree in scientific or related field.
- Minimum of 2-3 years of experience in Regulatory Affairs in the pharmaceutical industry and/or in Pharmacovigilance.
- Strong knowledge of regulatory/pharmacovigilance requirements and guidelines.
- Experience with product registration progress reports supplements and amendments.
- Experience with pharmacovigilance and safety reporting is an advantage.
- Familiarity with electronic records retention processes and controlled documentation systems.
- Excellent level of Czech (written and spoken) and very good level of English (written and spoken).
About the department
You will be part of a small dedicated team that is committed to ensuring regulatory compliance and patient safety. Our team works collaboratively to secure regulatory approval for new products and maintain compliance for existing ones. We also focus on safeguarding patients by monitoring and analysing safety data ensuring medicines are safe to use. Based in Prague the atmosphere in our department is supportive dynamic and purpose-driven where every team member plays a crucial role in achieving our mission.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with an unconventional spirit a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose mutual respect and a willingness to go beyond what we know delivers extraordinary results.
Deadline
Apply by Feb 8th 2026
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
You will be part of the Gulf Cluster sales team based in Qatar. You will report to the Country Sales Manager. The local team consists of approx 10 employees, and has highly-engaged and experienced members that are looking for a new teammember.
