Regulatory Affairs & Quality Manager (m/f/d)

About the job

As Regulatory Affairs & Quality Manager (m/f/d), you will take on a central role in ensuring the regulatory and quality-related requirements for our Swiss product portfolio. In doing so, you will work closely with local colleagues as well as international functions and make an important contribution to providing innovative therapies for patients.

Your Tasks

Regulatory Affairs

• Preparation, submission and follow-up of marketing authorisation applications for new medicines and new indications in collaboration with international regulatory affairs teams
• Creation and coordination of variations, renewals and other life-cycle management activities
• Communication with Swissmedic and coordination of regulatory queries
• Maintenance and updating of professional and patient information as well as coordination of internal approval processes
• Ensuring timely implementation of regulatory changes in packaging and product information
• Advising internal departments on regulatory issues and supporting the creation of information and marketing materials

Quality Management

• Deputising for the technically responsible person (FvP) for the Swiss market
• Supporting the market release of medicines as well as handling complaints and returns
• Contributing to the development and maintenance of the local quality management system
• Conducting and documenting quality-relevant training
• Supporting audits, inspections and the implementation of resulting measures

Cross-functional Support

• Processing, coordinating and documenting enquiries and responses on regulatory and quality-related topics
• Supporting the Market Access department in cost approval procedures according to Art. 71 KVV as well as related administrative processes

Your Profile

• University degree in pharmacy, natural sciences or a comparable qualifying education
• Several years of professional experience in regulatory affairs
• Knowledge of the Swiss medicinal products and authorisation environment as well as experience dealing with Swissmedic
• Ideally, initial experience in quality management and knowledge of relevant GMP and GDP requirements
• Structured, precise and analytical working style
• Ability to manage multiple projects simultaneously and reliably meet deadlines
• High initiative, flexibility and solution orientation
• Strong team and communication skills as well as enjoyment of cross-departmental collaboration
• Very good German and English skills


Are you passionate about regulatory tasks as well as quality management and want to work in a varied field of activity? Then please send us your complete application documents via our career portal . We look forward to hearing from you! You are also welcome to get a first impression at www.eisai.ch to get to know our company culture better.