JobMesh

Regulatory Strategy Associate Director

Vertex · CH

Job Description General Summary: - Reporting to the Senior Director of Regulatory Affairs, the Country Associate Director (AD) of Regulatory Affairs will pro...

Job description

Job Description General Summary: - Reporting to the Senior Director of Regulatory Affairs, the Country Associate Director (AD) of Regulatory Affairs will provide regional and local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices - This individual will be responsible for providing local regulatory expertise to ensure Vertex establishes and implements best practices in accordance with national requirements in Switzerland Key Duties and Responsibilities: Regulatory - Act as main contact with local National Health Authority (HA) Swissmedic for Regulatory Activities - Track all HA requests and relevant new local legislation and diligently forward to relevant GRA contact - Provide regional and local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner - Obtaining national regulatory intelligence through interaction with Swissmedic - Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as compassionate use, exemption from local label...