Regulatory Clinical Trial Submission Manager

  • Salary: .£32.25 per hour PAYE
  • REF Number: 00049301
  • Consultant: Julie Marshall
  • Contact: 01438 842964
  • Date Published: 18.11.2020
  • Sector: General Medical, Oncology
  • Location: High Wycombe, Bucks, London, South East
  • Discipline: Clinical Trials Administration, Regulatory Affairs

CK Group are recruiting for a Regulatory Clinical Trial Submission Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 12 months.

Company: Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies.

Location: This Regulatory Clinical Trial Submission Manager role will be based at our clients site in High Wycombe, Buckinghamshire.

Salary:

  • 32.25 per hourPAYE / £43.33 per hour LTD.

Regulatory Clinical Trial Submission Manager Role:

  • Ensure that the required regulatory intelligence is in place to comply with country-specific requirements.
  • Lead a cross-functional team that will compile, publish and produce Clinical Trial Authorisation Applications and associated CTA lifecycle submissions (e.g. Health Authority responses, amendments, etc.).
  • Be responsible for interactions with Health Authorities, and will be the primary contact pointwith regulatory authorities for communications relating to direct submissions of CTAs.
  • Ensure that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
  • If Clinical Research Organisations are contracted to handle some (or all) aspects as outlined above, you will be responsible for liaising with and overseeing CRO staff, as required.

Your Background:

  • Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
  • Experience within regulatory affairs in the pharmaceutical industry and an understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
  • Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
  • Must have strong project management skills (e.g. planning, prioritisation, management of schedules and timelines, detail orientation, strong sense of urgency).
  • Ability to lead complex projects and a high degree of problem-solving capability required. Must have a high level of self-awareness and adaptability and strong impact and influencing skills.

Apply: For more information or to apply for this Regulatory Clinical Trial Submission Manager position, please contact Julie on 01438 842964 or email pharmacontracts@ckagroup.co.uk, quoting job ref 49301.

It is essential that applicants hold entitlement to work in the UK.

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