About this role
Are you looking for a role where your regulatory expertise can directly shape the successful launch and lifecycle management of innovative pharmaceutical products? We are seeking a Regulatory Affairs Manager (80%) to help ensure our products meet local regulatory requirements and to support commercial success through strong cross-functional collaboration.
In this role, you will take ownership of regulatory activities across a portfolio of products, driving submissions, approvals, and maintenance of marketing authorisations in Switzerland. You will work closely with local and global colleagues, authorities, and internal stakeholders to help bring products to market and support their continued compliance throughout the product lifecycle.
Your responsibilities include:
Managing regulatory responsibilities for assigned products in line with the product responsibility listPreparing and submitting new product and new indication/line extension applications (CTD/eCTD)Maintaining and updating marketing authorisations for licensed products, including variations, renewals, and label changesEnsuring accurate compilation, tracking, and management of regulatory submissionsHandling label management activities, including artwork review and approval, in coordination with manufacturing, Demand Management, and QAPreparing and submitting PSURs and RMPsActing as a point of contact with Swissmedic and with AbbVie regional and global Regulatory Affairs teamsSupporting scientific advice, pre-submission, and clarification meetings with SwissmedicReviewing and approving promotional and non-promotional materialsSupporting product safety matters with Swissmedic and contributing to product actions, including recalls, in collaboration with PV, QA, Medical, and other functionsCommunicating safety-related label updates to relevant internal stakeholders in a timely mannerProviding regulatory intelligence to support launch planning and project teamsStaying up to date with Swiss regulatory requirements, authority processes, and the broader regulatory environmentEnsuring compliance with local and global SOPs and Good Documentation Practice A university degree in pharmacy or a relevant life sciences discipline; a Master’s degree is preferredAt least 5 years of experience in a similar Regulatory Affairs role within the pharmaceutical industrySolid experience with the registration of new products and new indications in the Swiss marketExperience with medical devices is an advantage, but not essentialExperience working in cross-functional brand teamsStrong organizational skills and a proven ability to meet deadlines and deliver resultsExcellent communication, negotiation, and influencing skillsStrong technical regulatory expertise and the ability to critically assess dataA proactive mindset with the ability to develop practical and innovative solutionsA collaborative, team-oriented approach and comfort working in a matrix environmentBusiness-fluent German and English; French is an asset
You’ll be joining a dynamic environment where regulatory expertise, collaboration, and business impact go hand in hand. If you enjoy working across functions, navigating complex regulatory requirements, and contributing to the success of important products, we’d love to hear from you.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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