Clinical Trial Regulatory Leader

Job type:
on-site
Start:
04/2014
Duration:
6 Months
From:
Real Staffing
Place:
High Wycombe
Date:
03/12/2014
Country:
flag_no United Kingdom
project ID:
677596

Warning
This project is archived and not active any more.
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This is an exciting opportunity to join a highly respeced global pharma as a Clinical Trial Regulatory Leader.

The successful candidate will
  • Be responsible for managing regulatory aspects for assigned clinical trials spanning a number of therapeutic areas
  • Be responsible for the overall trial submission strategy, and for the quality of regulatory submissions for CTAs, throughout the lifecycle of the trial
  • Ensure that the required regulatory intelligence is in place to comply with country specific requirements
  • Lead a team that will compile CTAs and associated CTA lifecycle submissions
  • Liase with and manage CRO staff if CRO is used


Experience:
  • Science degree or related experience within pharmaceutical industry
  • Ideally 3-6 years experience within regulatory affairs in the pharmaceutical industry
  • Strong understanding of Drug Development, Clinical Trial Authorization Applications, and general Regulatory Affairs


Desireable:
  • Strong communication skills
  • Strong project management skills
  • Ability to lead complex projects
  • Demonstrate problem solving skills
  • High level of self awareness and adaptability
  • Strong impact and influencing skills