Senior Regulatory Affairs Specialist

Summary: The Senior Regulatory Affairs Specialist will be responsible for the timely preparation and submission of Marketing Authorization applications for a biopharmaceutical company in Lucerne. The role involves managing regulatory objections, participating in product launch teams, and maintaining compliance for authorized products. This position is offered on a 12-month contract with potential for extension. Fluency in German and English is required, along with relevant experience in regulatory affairs.

Key Responsibilities:

• Ensure timely preparation and submission of new local Marketing Authorization applications for assigned products.
• Track process and manage responses to objections from regulatory authorities regarding product registration and new indications.
• Participate in product and launch teams to provide regulatory input and strategy advice.
• Maintain assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• Prepare and maintain local labels and packaging materials.
• Provide high-quality translations and checks of labels.
• Implement and use internal and external regulatory databases and systems efficiently.

Key Skills:

• Master’s degree in Pharmacy or relevant life science discipline.
• At least 2 years of experience in a registration department, regulatory agency, or related environment in Switzerland.
• Fluency in German and English; good level of French and/or Italian is advantageous.
• Familiarity with Swiss and EU legislation procedures and guidelines for pharmaceutical products.
• Knowledge of the regulatory framework for vaccines is advantageous.

Salary (Rate): 63.00

City: Lucerne

Country: Switzerland

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other