Are you a regulatory affairs expert ready for your next exciting challenge in the pharmaceutical sector? We are currently seeking a Senior Regulatory Affairs Specialist (m / f / d) to join a global pharmaceutical leader's local office in Lucerne, Switzerland.
This is a long-term opportunity starting asap, running through end of October 2026, with excellent prospects for professional development and the possibility of extension or a permanent position.
About the Role
In this role, you will report to the Regulatory Affairs Director and will be responsible for new marketing authorizations, variations, renewal applications, and maintenance of assigned, authorized products within the client franchise. You will develop local action plans for new products and maintain strong relationships with the pharmaceutical organization, local agencies, and other key regulatory stakeholders. Additionally, you will participate in subsidiary product and launch teams to provide regulatory input and strategic advice.
We are seeking candidates with a proven track record in drug regulatory affairs in Switzerland and a good understanding of relevant Swiss and/or EU legislation, procedures, and guidelines. Experience supporting product launches is preferred. Knowledge of vaccines or oncology products is beneficial but not required.
Key Responsibilities
* Ensure timely preparation and submission of new local Marketing Authorization applications and follow-up with authorities
* Track processes and manage responses to regulatory objections, including negotiations to optimize conditions
* Participate in product and launch teams for regulatory input and strategy
* Maintain authorized products through variations, renewals, and supplemental approvals
* Prepare and maintain local labels and packaging materials
* Ensure high-quality translations and label checks
* Utilize regulatory databases and systems efficiently within Switzerland
Your Profile
* Master’s degree in Pharmacy or a relevant life science discipline
* At least 2 years of experience in registration, regulatory agency, or related environment in Switzerland
* Familiarity with Swiss and EU pharmaceutical legislation and guidelines; vaccine regulatory knowledge is a plus
* Excellent verbal and written communication skills
* Strong attention to detail and ability to manage conflicting priorities
* Client-focused and business-oriented mindset
* Organizational and planning skills
* Proficient in MS Office and relevant databases
* Fluent in German and English; good knowledge of French and/or Italian is a plus
Why Apply?
* Join a forward-thinking organization where your regulatory expertise supports public health and patient access
* Work on a diverse product portfolio within an inclusive, high-performing team
* Location: Lucerne, Switzerland
* Contract Duration: 14+ months until October 2026
* Start Date: as soon as possible
LI-KK1 #LI-Hybrid
#J-18808-Ljbffr