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Regulatory Consultant

Central London   •  Negotiable  •  Permanent, Full time


Regulatory Consultant
Fully home based
Attractive package

Position Purpose:
The Regional/ Global CTA Submission Manager (CTA-SM) 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.

Some Role Responsibilities:

  • Drives global submission management strategy and activities for assigned protocols.
  • Lead and attends relevant meetings to advocate realistic deliverable timelines
  • Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
  • Responsible for the co-ordination of translations for core documents required for submission
  • Manages the compilation for core package build, contributing to CTA and authoring documentation as required
  • Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
  • Discussed with relevant SMEs the interpretation of dossier requirements

QUALIFICATIONS

  • B.S./B.Sc in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
  • In-depth understanding and proven execution of CTA and Central Ethics processes globally

If you are interested, then please apply or email directly at ed.taylor@cpl.com

  • Agency: Cpl Life Sciences
  • Contact: Ed Taylor
  • Reference: JO-2111-480946
  • Posted: 25th November 2021
  • Expires: 23rd December 2021

Cpl Life Sciences

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