Regulatory Administrative Expert (m/f)

near Zug  ‐ Onsite
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Keywords

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
Start date
ASAP
Duration
6 MM+
(extension possible)
From
Hays AG
Published at
04.04.2014
Contact person:
Kerstin Sieber
Project ID:
690304
Contract type
Freelance
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