Description
We are looking for a
Regulatory Administrative Expert (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: near Zug
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- The Regulatory Administrative Expert is responsible for accurate and timely compiling and dispatch of regulatory applications according to defined strategy, which includes:
- Timely compiling of regulatory package for new submissions
- Preparation of new packaging material for timely new submission according to the current Swissmedic requirements
- Finalisation of packaging material to ensure timely launch
- Ensure compliance of packaging material
- Ensure timely renewal of Marketing Authorisations
- Administrative support to Regulatory Manager for new submissions, obtain marketing authorizations and secure compliance
- Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time
- Establish a strong cross-functional relationship to other departments as well as with authorities
- Contribute to optimisation of internal processes and always work in accordance with Good Regulatory Practice
- Preparation of Packaging Material regulatory packages (quality, quantity and timely action)
- Timely renewals
- Transparent tracking of projects
- Regulatory compliance assured
- Business-oriented and timely interactions with key stakeholders
Your qualifications
- Education: Pharmaceutical/technical/medical associate education or similar education
- Languages: German, English, Desirable: French, Italian
- Experience: Office Skills, Organizational Skills, project management
Skills:
- Regulatory affairs assistant