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headcount AG , Zurich
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headcount AG , Zurich
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Senior Regulatory Affairs Manager – Drug Development
Website headcount
Senior Regulatory Affairs Manager – Drug Development
Location: Basel (hybrid).
Start: ASAP
Duration: 6 months
Workload: Full-time
Our client, a Swiss pharmaceutical company specializing in medicines for rare diseases, is seeking a Senior Regulatory Affairs Manager – Drug Development. This role will provide operational and strategic support for global regulatory activities across various phases, ensuring compliance with local and international regulations.
Your Tasks:
- Lead global regulatory activities, focusing on operational and strategic aspects of drug development, registration, and post-marketing.
- Provide regulatory input and support for Post-Approval Regulatory procedures, including variations, PSUR, MA annual re-assessments, scientific advice, and pediatric investigational plans.
- Manage Clinical Trial Authorisation applications and their maintenance, including amendments and notifications.
- Critically review regulatory documents such as IB, Protocol, and IMPD for accuracy and scientific validity.
- Oversee document management, ensuring proper filing and archiving as per internal SOPs.
Your Profile:
- Bachelor’s degree in life sciences or related field.
- Over 8 years of experience in a similar role within a pharmaceutical company or CRO.
- Strong knowledge of EU/US clinical trial guidelines and regulations.
- Proven experience managing clinical trial applications and working within matrix organizations.
Please apply directly online with your CV.
**Please only apply if you are eligible to work in Switzerland and the EU**
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