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Job Details

International DRA Project Manager

Company: CTC Resourcing Solutions
Location: Basel
Reference: 895650-P
Closing Date: 21 Mar 18
Type: Contract
Salary (£): Competitive

Job Summary:

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

Apply for this job: International DRA Project Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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