Regulatory consultant with Swissmedic experience

We are looking for an experienced consultant in regulatory affairs with expertise in the Swiss regulatory affairs environment & navigating Swissmedic processes.

     Responsibilities
As a consultant you will provide strategic and operational regulatory support within drug development at a national level. Your responsibilities will include managing and participating in complex and challenging projects from international and local companies across various therapeutic areas.

    Regulatory Strategy with Swissmedic focus:

• Provide regulatory support to clients, propose registration strategies for new product developments, line extensions, and product maintenance plans.
• Advise on the content and timing of submissions particularly for Swissmedic submissions
• Provide regulatory advice on drug development strategies from early stage to marketing authorisation applications, variations, and renewals
• Support clients in organising and conducting scientific advice procedures and other meetings with Swissmedic. Including preparing briefing documents, managing relevant contacts and meetings
• Marketing authorisation applications & license maintenance
• Manage marketing authorization applications for Swissmedic, overseeing coordination and responses to authority questions, along with post-marketing commitments
• Co-ordinate and support preparation of regulatory documents (e.g., Swiss Module 1, including product information and mock-ups,)
• Manage license maintenance applications, including variations, line extensions, renewals, and PSUR submissions, under the respective scheme
• Ensure content and format of CTD documentation comply with current requirements and guidelines
• Act as a Swissmedic specialist for international collaboration projects such as Project Orbis and Access Consortium
• Advise and support clients with Swiss MAA and MAH requirements
  
  Qualifications / Experience
• A university degree in a scientific discipline
• Experience in the Swiss regulatory affairs environment
• Experience in regulatory writing (e.g., Scientific Advice Briefing Book, CTD Modules, ODD applications)
• Proficient in German and English; additional proficiency in French and/or Italian is advantageous
• Demonstrate excellent communication skills and a high level of intercultural awareness

    Application & Contact

Send your application (CV and letter) to Recruitment@ndareg.com with the subject line: Consultant, Switzerland