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Regulatory Affairs Specialist

Berkshire   •  Negotiable  •  Permanent, Full time


Regulatory CTA Submissions Specialist

12 month contract (Inside IR35)

Berkshire based Hybrid working flexibility

Offering up to 45.00 Per Hour via PAYE DOE

CPL Life Sciences are partnering with a Top 10 Pharma who currently have multiple Regulatory CTA Submission Specialist vacancies. Due to an increase in Clinical Trial Submissions, these opportunities are for 12 months offering flexibility working from their Berkshire office. You shall be responsible for global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.

Main Responsibilities includes;

-Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities

- Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments

- Ensure approved company CTA processes are followed within agreed timelines

- Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.

Candidate Requirements includes;

  • Eligibility to live and work in the United Kingdom
  • Life Sciences degree or equivalent
  • Preference for 2 years Regulatory CTA experience within global clinical trial submissions
  • Good organisation and time management

If this opportunity is of interest to yourself please forward your CV to Sophie.Malyon@cpl.com .

  • Agency: Cpl Life Sciences
  • Reference: JO-2206-494474
  • Posted: 9th June 2022
  • Expires: 7th July 2022

Cpl Life Sciences

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