Senior Manager Regulatory Affairs CMC Cardio-Renal – St Gallen

Vifor Pharma — St. Gallen
17.10.2019 | Employee | 100%

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

This website uses cookies to ensure you receive the best service. Further information can be found in our Terms and Conditions and in the Privacy Policy.