Title : Sr. RA Manager
Location: Zug, Switzerland ( 3 days onsite per week) Job Overview
Serves as a core member of the Swiss Affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders
Ensures that Client complies with country’s applicable legislations and regulations linked to the Marketing Authorization (MA) / local license as MA Holder
Ensures that the medicinal products in his/her responsibility can be developed, authorized and maintained on the market
Serves as a core member or may lead project teams locally and may lead local initiatives. May also participate in above country teams Job Responsibilities
Manages or prepares technically complex regulatory submissions to local Health Authority (HA), including initial MA application, variations, safety reports, risk minimization measures, Dear Healthcare Provider Communications, compassionate use, early access, license renewals as well as clinical trial applications and amendments, which may require extensive interaction with departments outside of Regulatory Affairs (RA)
Ensures compliant labeling for Client medicinal products and manages timely updates for assigned product(s)
Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up
Provides strategic regulatory advice, as appropriate including input into clinical development programs
May manage a team of Regulatory professionals or lead the country Regulatory activities
• Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
• Helps ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert or the management of audits and inspections within the affiliate
• Initiates local process improvements and contributes to local and/or global process improvements which have a signi...