Pharmaceutical Affairs
vor 2 Monaten
Do you want to make a difference? Then join Aspen Pharma Schweiz GmbH and help shape the future As the regional subsidiary of the international pharmaceutical company Aspen Pharmacare, headquartered in Durban, South Africa, we combine the best of both worlds: short decision-making processes, a motivated and friendly team with great individual creative freedom in Switzerland, embedded in a large, multinational, and diverse organization with professional structures and an exciting product portfolio.
To strengthen our Swiss team at the location Baar, we are looking for a Pharmaceutical Affairs (Quality & Regulatory Affairs) Manager with heart, dedication and competence.
**Your Responsibilities**
**Regulatory related**:
- Management of regulatory submissions as per regulatory plan - quality variations, safety variations, new registrations
- Artworks - providing regulatory input and approval
- Maintenance of RA related databases
- Interaction with Swissmedic
- CPP Applications
**Quality related**:
- Maintenance of the Quality Management System
- Management of complaints
- Assessment of Product Quality Reviews
- Market release activities
- Vendor qualification
- Fulfilling the role of the Deputy Responsible Person
**Your Qualifications**
- University degree in natural sciences or an equivalent qualification
- Knowledge and experience in acting as the regulatory interface between Swissmedic and the Group Regulatory Affairs department (submission of variations, renewals, safety-related submissions, artwork handling and submission, systematic tracking of activities)
- Proficiency in local languages (German, ideally also French) as well as excellent English skills
- Strong communication and teamwork skills to collaborate effectively with various departments
- Independent, structured, and results-oriented working style
**About Aspen**
**Why should you Join us**
In addition to a first-class working environment with exciting tasks in a growing company, we offer an attractive salary and benefits package, the possibility of mobile working, and a permanent position.
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