Regulatory Consultant with Swissmedic Experience

vor 3 Wochen

RapperswilJona, Schweiz NDA Regulatory Service Switzerland GmbH Vollzeit

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
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

Co-ordinate and support preparation of regulatory documents (e.g., Swiss Module 1, including product information and mock-ups,)
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
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

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