Regulatory Affairs CMC Manager – St Gallen
We are currently looking for a Regulatory Affairs CMC Manager to join our Regulatory Affairs team. This role reports directly to the Head Regulatory Affairs CMC and is planned to be based in St Gallen.
Your responsibilities will include:
- Prepare and maintain up-to-date CMC/Module 3 documentation and CMC-related documents compliant with requirements of Health Authorities and international guidelines.
- Ensure input and review by Production and Technical units and consistency across all products.
- Represent Regulatory Affairs in Project Teams. Provide input as a regulatory expert on questions concerning CMC/Module 3 documentation and regulations.
- Help to develop submission strategies for investigational medicinal product dossiers, new registrations and technical changes during life cycle.
- Coordinate the responses to Deficiency Letters related to CMC.
- Attend HA meetings in case of quality topics and prepare CMC briefing packages.
- Change Control: Coordinate the global regulatory assessment of CMC-changes.
- Contribute to the continuous improvement of workflows and systems.
The successful candidate is able to work efficiently with a wide variety of personnel across diverse teams and functions internally as well as external partners. In addition, you will bring the following profile:
- Scientific background
- Degree in Pharmacy, Natural Sciences, Chemistry or equivalent
- Minimum 5 years of work experience in Regulatory Affairs and proven expertise in CMC.
- Experience in leading regulatory projects, working in cross-functional teams and on international registrations
- IT-skills; familiar with use of standard software & tools (Windows, Word, Excel, PowerPoint, Visio, MS-Project), databases (e.g. TrackWise, electronic Document Management Systems)
- German speaking and good command of both, written and spoken English language is mandatory
You describe yourself as a good communicator, with strong teamwork skills as well as good organization and negotiation abilities. You demonstrate accuracy and attention to details with a focus on quality and regulatory requirements. Finally, you are able to cope with stress and demonstrate discretion in the handling of confidential information