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CTA Submissions Manager

  1. Home Counties
  1. Contract
Competitive
24146- ML
  1. Drug Safety / Pharmacovigilance
Date Posted08 Jan 2020
Our global client based in the leafy Buckinghamshire area is now looking for a Regulatory Clinical Trial Application Submission Manager to join our client on a new and exciting contract.

This will be for a period or around 6 months with a view to be remotely based after the initial settling in period.

This position is responsible for managing Clinical Trial Applications submission activities for assigned clinical trials - Phase 1 - 4 - mainly Pulmonary Hypertension.
Candidates looking to be selected for this position will need to have experience in regulatory CTA submission regulations and the requirements will be, to be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trials
We are offering a highly competitive hourly rate for this position, plus the opportunity to work within an established and fun team.


Responsibilities:
  • The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team
  • The CTA submission manager will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
  • The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
  • The CTA submission manager manages the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.

If you feel this is the ideal role for you and would like to work for this fantastic company, then please apply now!




The candidate must have the rights to work in the location stated in the job advert.

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