Informacje o stanowisku

The position

As a Regulatory Affairs Specialist, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). You will ensure Regulatory Affairs compliance according to local legislation and Standard Operating Procedures (SOPs). Your main responsibilities will include:

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

Qualifications

To be considered for this position you need to be accurate and detail-oriented. You will be accountable and committed to the implementation of the assigned tasks and show the ability to work independently and as part of a team. You are an excellent communicator with established time management skills. Moreover, you will present:

1. University degree, preferably within pharmacy/biology/chemistry or similar.
2. Minimum 2 years’ experience in Regulatory Affairs.
3. Analytical skills and attention to detail.
4. Ability to work independently and as part of a team.
5. Fluency in English (written and spoken), while proficiency in the local language.

About the Department

Our Regulatory Affairs and Pharmacovigilance Team is responsible for all Novo Nordisk medicinal products and medical devices available in Poland. We are the integrated part of Clinical, Medical and Regulatory Department in Novo Nordisk Poland. As we share functions, there is a strong collaboration between Regulatory and Pharmacovigilance functions and with regional/global teams.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic 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. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

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