74 days ago on ctcon.ch

Senior International DRA Project Manager

CTC Clinical Trial Consulting AG

  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Senior International DRA Project Manager

Reference Number: 895107-W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

In the role of Senior DRA coordinator, the candidate will liaise and coordinates all documentation, submissions and activities with affiliates and partners.

Main Responsibilities:

  • Provides 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
  • Responds to Health Authority questions in coordination with Global DRA Project Leader and project team
  • Applies for the preparation and shipment of registration samples
  • Coordinates the archiving of submitted registration dossiers and other relevant Health Authority communications
  • Evaluates and reviews the regulatory activities of potential and existing business partners contracts and quotations
  • Deputizing the Group Leader, as necessary
  • Opportunity to mentor the Junior International DRA Project

Qualifications and Experience:

  • Degree in life science and at least 5 years previous experience working in regulatory affairs, preferably with regions outside of the EU and US
  • Good knowledge of international regulatory legislation and guidelines
  • Ability to work in multicultural environment
  • Excellent communication, interpersonal, negotiation and problem solving skills
  • Capable of working independently as well as effective team player
  • Accuracy and good project management skills
  • Excellent command of spoken and written English, other languages are advantage
  • Management experience is an advantage