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Regulatory Affairs Associate CTA

ARM LifeSciences
Job LocationUxbridge
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

ARM is currently supporting a well renowned pharmaceutical company that is looking to bring on a Regulatory Affairs professional on a contract basis.Sitting within the General Medicines team, this position offers a great opportunity to join an experienced team working on exciting early phase products, within a multinational team. There will be a core focus on supporting CTAs for marketed products, providing assistance throughout various phases in the products lifecycle.As such we are looking for a candidate with previous CTA experience who is looking to secure a position where they can take ownership of their work and deliver key submissions for business critical projects.What you will be doing:

  • Maintain ongoing clinical trial activities via protocol amendments, IB updates etc via completing assessment for reportability (Substantial and non-substantial amendments and urgent safety measures).
  • Complete all end of trial activities in line with GCP, country requirements and company standard operating procedures.
  • Collaborate with regional affiliates to provide submission components for national or VHP clinical trial applications.
  • Coordinate collection of functional documents in support of regulatory applications. As appropriate participate in GRT to support execution of regulatory strategy
  • Coordinate QC of regulatory documentation (related to clinical trial applications). Provide primary authorship to routine regulatory correspondence for CTAs.
  • Prepare regulatory packages and cross-reference letters to support investigator-initiated studies.
  • Approve drug shipment for company and Investigator Initiated Studies Complete regulatory forms to support agency communications
  • Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams for CTA related activities.
  • Actively support regulatory compliance Support the development and execution of GRT goals
    • What you will need
  • 1-2 years’ experience working within a RA role supporting CTA activities
  • Understanding EU clinical trial application process and requirements set out as per GCP and EudraLex - Volume 10.
  • Accustomed to leading National or VHP new CTA submission while providing regional preferences to meet study team goals.

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