Senior Specialist Drug Regulatory Affairs (m/f/x) | Zurich | Pharma
In this position, you will be responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for medicinal products and communication of general regulatory requirements in support of licensing of the company's medicinal products, primarily in Switzerland but also in the DACH-region.
What will your tasks as "Senior Specialist Drug Regulatory Affairs (m/f/x)" be?
- Compile and submit, in a timely matter, regulatory documents according to regulatory requirements, with regulatory experience on local level, e.g., Swissmedic submissions, eCTD submissions and Lifecycle Management
- Manage all regulatory activities in relation to a specific portfolio of drugs (product owner)
- Respond to Swissmedic questions with strict deadlines
- Maintain regulatory files in a format consistent with requirements
- Obtain, maintain, and update existing regulatory authorizations
- Provide regulatory advice to project teams
- Lead or represent Regulatory Affairs in project teams
- Review promotional material for comp
Your requirements as "Senior Specialist Drug Regulatory Affairs (m/f/x)"?
- University degree in pharmacy or related scientific discipline; PhD will be an advantage
- 3-5 years experience of working in Regulatory Affairs within a pharmaceutical company, Swissmedic, CRO or similar organization
- Experience of working with Swissmedic
- Proven ability to plan, coordinate and lead submission activities simultaneously
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well-organised and self-motivated
- Fluency in German and English; French and / or Italian language skills would be an advantage
Information about our client:
Our client is one of the largest pharmaceuticals & medical devices companies in the world. It's more than 40.000 employees are operating in 90+ countries. The diverse specialties of the company include critical care, hospital care as well as nutritional care and renal care. The company is striving for excellence by helping improve and personalize healthcare.
I look forward to your application!