Regulatory Affairs Manager
vor 16 Stunden
**Regulatory Affairs Manager (M/F)**
**Contract limited**
**This is what you can look forward to**:
- Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background
- Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc.
- Developing of submission strategies to enhance the product value and expedite pathways
- Collaborating with local and global regulatory and cross-functional colleagues
- Acting as reliable and competent contact for Swissmedic
**What you offer**:
- Academic degree in natural sciences
- At least 3 year experience in Swiss Regulatory Affairs
- Knowledge of or experience in project management techniques is of advantage
- Extensive knowledge of the current Swiss regulatory and drug laws environment, knowledge about other legal environments (EU, US, etc.) is of advantage
- Very good knowledge of German and English, good knowledge of French and/or Italian is of advantage
- Solid knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine
- Good computer skills
- Strong skills in productivity, organizational and time management
- Highest quality standards
- Demonstrated ability to foster teamwork
**Convinced?**
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Regulatory Affairs
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