Regulatory Affairs Manager Switzerland (m/f/d)

About the job

To support our Regulatory Affairs team in Switzerland, we are looking for a part-time (50%-60% workload) Regulatory Affairs Manager for our location in Zurich as soon as possible:

Regulatory Affairs Manager Switzerland (m/f/d)

In this role, you will take on a key position in ensuring the market authorisation and compliance of our products. You will actively participate in regulatory processes, maintain close contact with authorities, and contribute to the continuous development of our regulatory strategies.

Your tasks:

• Responsibility for compliance with all regulatory and legal requirements for medicinal products in Switzerland
• Organisation and monitoring of Swiss authorisation processes
• Development and implementation of authorisation strategies for new products and existing portfolios
• Responsibility for maintaining authorisations of medicinal products registered in Switzerland (Life Cycle Management), including evaluation of change applications and preparation of required documents
• Contact person for Swissmedic for products within the area of responsibility
• Active participation in European and global product-specific meetings, regular exchange with national and international Regulatory Affairs colleagues
• Participation in European Regulatory face-to-face meetings
• Cross-departmental collaboration with interfaces within the company
• Monitoring regulatory developments, developing and implementing necessary measures
• Deputising for the Senior Regulatory Affairs Manager DACH

Your profile:

• Degree in a scientific discipline (pharmacy, biology, chemistry or other scientific education)
• Several years of professional experience dealing with Swissmedic authorisations and regulations
• Knowledge of Swiss medicinal product law and regulatory requirements
• Team player with strong communication skills as well as a structured, independent and solution-oriented working style
• Experience in working with authorities, especially Swissmedic
• Confident use of Microsoft Office products and quick familiarisation with the necessary IT programmes for the work area
• eCTD knowledge is an advantage
• Native German speaker, very good English skills (French or Italian an advantage)

Our offer:

At Otsuka DACH, the advantages of a large corporation are combined with those of a small company. We benefit from financial security and infrastructure as well as direct decision-making paths and flat hierarchies. We all know each other personally, work together and support each other – we are a team!

You can expect a colourful range of benefits, such as an Employee Assistance Programme, the option of additional days off or individual training opportunities.

Your way to us:

Please send your complete application documents in the first step, indicating your possible starting date and salary expectations, preferably via our homepage .

If you have any questions about Otsuka or the vacancy, please feel free to contact Nicole Schuhbeck by e-mail. E-mail: nschuhbeck@otsuka.de