Regulatory Affairs Manager (80%)

Poste

Temps partiel

Permanent

Mid

Autre

Modalités

Cham, ZG, Switzerland

80%

Clôture dans 30 jours

Exigences

5+ ans d'exp.

Master

Permis UE/AELE

Langues

Allemand C1

Anglais C1

Français

Description

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.

Responsabilités

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

Exigences

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

Avantages

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.

Entreprise

abbvie

Pharmaceuticals

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.