MSD is currently seeking a Senior Regulatory Affairs Specialist to join our local office in Lucerne, serving the Swiss healthcare market.
Reporting to the Regulatory Affairs Director, you will be responsible for managing new marketing authorizations, variations, renewal applications, and maintaining assigned authorized products within the MSD franchise. Your role will include developing local action plans for new products, maintaining strong relationships with the pharmaceutical organization, local agencies, and key regulatory stakeholders. Additionally, you will participate in subsidiary product and launch teams to provide regulatory input and strategic advice.
We are looking for candidates with:
* Experience in drug regulatory affairs in Switzerland
* Good understanding of Swiss and/or EU legislation, procedures, and guidelines
* Experience supporting product launches (preferred)
* Knowledge in vaccines or oncology products (beneficial but not required)
Main responsibilities include:
* Preparing and submitting local Marketing Authorization applications timely and following up with authorities
* Managing responses to regulatory objections and negotiating optimal conditions
* Providing regulatory input for product launches and strategy
* Maintaining authorized products through variations, renewals, and supplemental authorizations
* Managing local labels and packaging materials, ensuring quality translations and checks
* Using regulatory databases and systems efficiently in Switzerland
Qualifications:
* Master’s degree in Pharmacy or relevant life sciences
* At least 2 years of experience in registration, regulatory agency, or related environment in Switzerland
* Fluency in German and English; proficiency in French and/or Italian is a plus
* Familiarity with Swiss and EU pharmaceutical legislation and guidelines
* Excellent verbal and written communication skills
* Attention to detail and ability to manage conflicting priorities
* Client-focused and business-oriented mindset
* Strong organizational and planning skills
* Proficiency in MS Office and relevant databases
This is a temporary role. Further details will be provided upon application.
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