Senior Manager Regulatory Affairs CMC Cardio-Renal – St Gallen
We are currently looking for a Senior Manager Regulatory Affairs CMC Cardio-Renal 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:
- Manage the assigned RA-CMC-Team: providing guidance and sharing expertise with RA-CMC-Team
- People Management; Development of team-members, goal setting and individual performance and development reviews.
- Manage the Regulatory CMC – projects for the assigned portfolio:
- Ensure proper planning and coordination in order to achieve company goals and wise use of available resources.
- Prepare and maintain up-to-date CMC/Module 3 documentation and CMC-related documents in alignment with the information received from RA-TA, RA-PB and the technical departments and in accordance with the requirements of the Health Authorities and international guidelines (ICH).
- Participate and represent Regulatory in Project and/or Technical Teams. Provide input as a technical 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.
- Provide expertise on questions concerning CMC (e.g. documentation, regulations, strategies)
- Attend HA meetings in case of quality topics and prepare CMC briefing packages.
- Provide input to the GRA budgeting process
- Ensure alignment between GRA-Groups and technical departments
- Change control: Coordinate the global regulatory assessment related to CMC
- Contribute to the improvement of departmental and cross-functional processes.
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
- 6 to 10 years of work experience in Regulatory Affairs
- Proven expertise in CMC
- Experience in people management
- Leadership experience in projects
- Leadership qualities, diplomacy and respectful behavior
- IT-skills; familiar with use of standard software & tools (Windows, Word, Excel, PowerPoint, Visio, MS-Project), databases (e.g. TrackWise, electronic Document Management System)
- German speaking, with a 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