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.

Your responsibilities include:

• 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

Qualifications :

• A university degree in pharmacy or a relevant life sciences discipline; a Masters 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

Youll 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 wed love to hear from you.

Additional Information :

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

Work :

No

Employment Type :

Part-time