Regulatory Manager

Key Responsibilities Provide strategic guidance on regulatory requirements and submissions, first in Switzerland, but later also in the EU Actively manage relationships with Swissmedic, EMEA and potentially other regulatory agencies Navigate the Swiss Regulatory Ecosystem, including being connected to professional working groups Diretcly manage Swiss National dossier filings & other EU filings and contribute to centralized dossier preparation Offer expert advice on new product applications and lifecycle maintenance Lead small-scale projects or work streams, ensuring client satisfaction and project success Collaborate with cross-functional teams to deliver high-quality regulatory solutions with ambitious timing requirements Your Profile Master degree in life sciences, pharmacy studies or related areas. Must have worked in a key regulatory function in the Swiss affiliate of a pharmaceutical company for several years, having had a QP/RP responsibility to Swissmedic is an advantage. Has successfully managed at least 1-2 launches of generics and/or NCEs in regulatory affairs in Swiss Market, practical launch experience through EMEA centralised procedure is a strong advantage Existing network to Swissmedic, BfArM, and other EU national Health Authorities is a strong advantage In-depth knowledge of international regulatory requirements Strong understanding of EU regulatory landscape Excellent project management and client communication skills Ability to work independently and as part of a team Proactive problem-solver with keen attention to detail Fluent English and German speaker (required) #J-18808-Ljbffr Execruit