International DRA Project Manager

Inactive

Reference Number: 895650-W
Type of placement: Contract, 12 Months
Location: Switzerland, North West

Introduction:

For one of our clients, a multinational pharmaceutical company, we are currently looking for an International DRA Project Manager

Main Responsibilities:

  • Under the supervision of the International DRA Project Manager:
    • Provide regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
    • Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
    • Liaise and coordinates all documentation, submissions and activities with affiliates /partners for NCE dossiers and life cycle of marketed products
    • Respond to Health Authority questions in coordination with Global DRA Project manager and project team
    • Coordinate Registration Samples
    • Coordinate archiving of submitted registration dossiers and other relevant Health Authority communications
    • Evaluate and review regulatory parts of contracts and CRO quotations
  • Support the International DRA Project Managers in developing and executing defined regulatory plans
  • Demonstrate the ability to propose solutions for potential problems/challenges
  • Responsible for accuracy and integrity of the tasks assigned by his/her supervisor
  • Ability to keep data, related documentation, and files in a well-organized manner
  • Follow internal guidelines, working practices, SOPs and regulatory guidelines
  • Report all activities to the International DRA Project Manager on a monthly basis or as requested

Qualifications and Experience:

  • Degree in life science preferable and at least 2 years experience in regulatory affairs
  • Knowledge and experience of global regulatory processes
  • Ability to work in multicultural environment
  • Excellent communication and interpersonal skills
  • Capable of working independently as well as effective team player
  • Accuracy and good project management skills
  • Excellent command of spoken and written English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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