Junior Regulatory Affairs Officer

il y a 2 semaines

Vilvoorde, Belgique Sandoz Temps plein

#1 Sandoz was the first pharmaceutical company to receive approval of a biosimilar in Europe, Japan, and the United States. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
- The Junior Regulatory Affairs Officer
- Within the Pharmaceutical Affairs and Product Life-cycle Management (PA&PLM) department, the Junior Regulatory Affairs Officer is responsible for the execution of specific Regulatory Affairs tasks for the Sandoz BeLux portfolio.
- Your responsibilities:
- Life-cycle management of registrations for medicinal products (variations and renewals)
- Preparation of national registration documents required for variations
- Organizing and reviewing translations of product information (summary of product characteristics, patient leaflet and labeling)
- Review of artworks
- Communication with the local health authorities (Federal Agency for Medicines and Health Products)
- Maintenance of databases and registration documents

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- What you’ll bring to the role:
- University degree in a relevant field (e.g. pharmacy, chemistry, biology or similar)
- Accuracy is a key element of your personality at work
- High quality awareness
- Enthusiastic and motivated
- Team player
- Good knowledge of Dutch, French and English
- Knowledge of Microsoft Office (Outlook, Word, Excel)

You’ll receive:

- We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Sandoz. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Your office will be based in Vilvoorde.
- Why Sandoz?
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Sandoz
- Commitment to Diversity & Inclusion:

- Sandoz embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

**Division**
- SANDOZ

**Business Unit**
- COMMERCIAL OPS EUROPE SZ

**Country**
- Belgium

**Work Location**
- Vilvoorde

**Company/Legal Entity**
- SDZ BEL

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Temporary

**Shift Work**
- No

**Early Talent**
- No

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