Regulatory Affairs Manager (80%)

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.

Managing regulatory responsibilities for assigned products in line with the product responsibility list

Preparing 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 changes

Ensuring accurate compilation, tracking, and management of regulatory submissions

Handling label management activities, including artwork review and approval, in coordination with manufacturing, Demand Management, and QA

Preparing and submitting PSURs and RMPs

Acting as a point of contact with Swissmedic and with AbbVie regional and global Regulatory Affairs teams

Supporting scientific advice, pre-submission, and clarification meetings with Swissmedic

Reviewing and approving promotional and non-promotional materials

Supporting product safety matters with Swissmedic and contributing to product actions, including recalls, in collaboration with PV, QA, Medical, and other functions

Communicating safety-related label updates to relevant internal stakeholders in a timely manner

Providing regulatory intelligence to support launch planning and project teams

Staying up to date with Swiss regulatory requirements, authority processes, and the broader regulatory environment

Ensuring 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 preferred

At least 5 years of experience in a similar Regulatory Affairs role within the pharmaceutical industry

Solid experience with the registration of new products and new indications in the Swiss market

Experience with medical devices is an advantage, but not essential

Experience working in cross-functional brand teams

Strong organizational skills and a proven ability to meet deadlines and deliver results

Excellent communication, negotiation, and influencing skills

Strong technical regulatory expertise and the ability to critically assess data

A proactive mindset with the ability to develop practical and innovative solutions

A collaborative, team-oriented approach and comfort working in a matrix environment

Business-fluent German and English; French is an asset

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html