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Senior CTA Submissions Manager - remote role

Zoek Pin London EC2V, UK

Competitive

Permanent (Full time)

DETAILS:

Please make an application promptly if you are a good match for this role due to high levels of interest.

  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Remote working in the UK
  • Competitive hourly rate of pay
  • Global pharma compa THE ROLE:
  • Provides an interface to Regulatory and partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to regional partners and selected Health Authorities.
  • The Senior Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs.

They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.

  • The GSM may be assigned as a Hub Submission Manager to meet business demands.

In this capacity, they may operate as Subject Matter Expert for a selected geography Full job description available on application THE CANDIDATE:

  • ./ is in Pharmacy, Life Sciences etc
  • UK regulatory affairs experience essential
  • In-depth understanding and proven execution of CTA processes globally
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
  • Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
  • Understanding of EU Clinical Trial Regulation Desirable
  • Only candidates with existing right to work in the UK/EU will be considered

Posted 6 days ago

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