We have a current opportunity for a Regulatory Affairs Manager on a contract basis. The position will be based in Zug. For further information about this position please apply.
Responsibilities:
- Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives.
- Leads the regulatory submissions of clinical trial applications (CTA) and amendments in Europe (EU, UK (post-Brexit) and Switzerland).
- Manages regulatory affairs consultants/service providers working on the CTA submissions
- Anticipates and brings solutions for potential regulatory risks
- Maintains excellent knowledge of the European regulatory landscape and pro-actively assesses impact of changes on programs
Your Profile:
- Minimum of 5 years of experience managing regulatory submissions, with a primary focus on clinical trial applications and associated tasks
- BSc; MSc or PhD in a life sciences discipline
- Fluent in English (written and spoken)
- Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union
