Regulatory Start Up Manager
Premier Research
Warsaw, Poland
6 d. temu

Description

Position at Premier Research Group Limited

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality.

We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.

You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

Imagine. Inspire. Innovate. Impact. With Us.

We’re looking for a Regulatory Start Up Manager to join our team! This is a permanent role to be either office based or home based in Warsaw, Poland.

The Regulatory Start-Up Manager (RSM) is responsible for the coordination and strategic planning of all country Competent Authority (CA), central / local Ethics Committee submission (LEC / CEC) as well as any additional board / evaluating body required to obtain study approval that allow the conduct of clinical research within the countries required.

You will be accountable for :

  • Developing the Regulatory & start-up submission project plan. Is the driver for CA, EC and LEC submission as well other boards / evaluating bodies, import and export licenses, where applicable.
  • The pertinent notifications throughout the trial (e.g. First patient-in, End of Trial)
  • The liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables?
  • For identifying & communicating country timelines to our clients and project teams
  • For identifying & communicating risks and contingency plans related to start up activities to our clients and project teams
  • Overseeing the site contract execution process in the studies that a Contracts Lead is not assigned.
  • Obtaining the EudraCT number where delegated by Sponsor
  • Generating and obtaining the appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
  • Reviewing master IP labels and provides feedback on its potential acceptability to regulatory authorities including issues related to country adaptation
  • To be successful in this role you will need :

  • Education to university degree level in pharmacy, medicine or related natural sciences
  • Previous professional experience, including previous experience in Regulatory or Start-up functions at a ideally a Global level
  • To be able to perform the role of Regulatory Lead (RL) for newly awarded studies containing countries from the same region, and may take a multi-
  • region study in Start-up under supervision, or maintenance studies independently

  • Prior hands-on experience in the submission of clinical trial applications
  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and start-up procedures.
  • Ability to read, write, and speak fluent English; fluent in host country language.
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