Regulatory Administrative Expert (m/f)

REFERENZNUMMER:

234196/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-Education: Pharmaceutical/technical/medical associate education or similar education
-Languages: German, English, Desirable: French, Italian
-Experience: Office Skills, Organizational Skills, project management

WEITERE QUALIFIKATIONEN:

Regulatory affairs assistant