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)
Job Features
| Job Category | REGULATORY AFFAIRS |