Cmc & Regulatory Affairs Manager (100%)
Vor 3 Tagen
LimmaTech Biologics AG is a clinical stage biopharmaceutical company active in the vaccine field. We develop new generations of bioconjugate vaccines against major bacterial diseases and are expanding our capabilities into later stage development.
We are currently looking for a:
**CMC & Regulatory Affairs Manager (100%)**
Your responsibilities will include:
- Establishing, leading, and driving the global CMC operational and regulatory activities for one of our vaccine products to achieve market authorization
- Selecting and managing partners for phase II/III CMC activities for both API and IMP manufacturing
- Leading and driving global CMC submission activities
- Representing Global Regulatory CMC on cross-functional project teams and maintaining collaborative networks with key stakeholders
- Initiating, maintaining, and leading Health Authority interactions and negotiations, setting objectives and risk mitigation plans
- Providing strategic advice and direction within the department and cross-functionally through specialized assignments
You are an efficient and enthusiastic multi-cultural team player with:
- Proven track record of successfully managing CMC campaigns for biologics (phase I, II, and/or III)
- Technical experience in QbD, process and analytical validation, CMC-bridging strategies
- Substantial expertise and experience in regulatory affairs, preferably for biologics
- Positive, proactive, goal oriented can-do attitude
- Focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
- Strong project management skills
- Excellent verbal and written communication skills in English
The working place is in Schlieren near Zürich, easily accessible by public transportation. If you meet the requirements of this exciting position and want to work in a friendly, highly motivated and dynamic team, we are interested in hearing from you.
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