Clinical Trial Regulatory Leader

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Start date:
Lawrence Harvey Group - Pharmaceuticals
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flag_no United Kingdom
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I am working on a brand new very exciting 6 month contract role as a Clinical Trial Regulatory Leader, for a leading global pharmaceutical company.

The role is based in Buckinghamshire and my client is offering very competitive day rates.

The successful candidate will be responsible for managing regulatory aspects for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).

The CTRL will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.

For this role you will ideally have the following experience:

* Lead CTA Working Groups throughout entire CTA life cycle

* Possess a minimum of 4-6 years' experience within regulatory affairs in the pharmaceutical industry

* Provide country-specific input on document requirements, timing, and processes for CTA applications
* Manage development of the CTA submission strategy for assigned trials

* Drive interaction with local (country) staff to develop timelines and obtain locally-provided CTA documents

* Complete locally-required activities, where applicable, such as application forms, applying for CTA numbers from Health Authorities, arranging for payment of fees

* Ensure that all required centrally-produced required documents are included in the dossier

* Liaise with publishing staff to ensure that country-specific dossiers are provided, including incorporation of locally-provided documents, as possible, in the completed dossier

* Ensure dispatch of applications to Health Authorities (HAs) or other designated company representatives

* Manage Health Authority Interactions for all (both central and local) CTA submissions (eg, follow-up on status of application review with HAs; receive HA questions and coordinate responses appropriately, etc.)

* Ensure that Regulatory staff (Global Regulatory Leader, Regional regulatory staff, Regional liaisons) and clinical trial staff are kept up-to-date on status of the application and HA queries throughout the project duration

* Manage Output Protection Process for assigned trials

* Ensure tracking of key information (including dates of submission and approval, status, HA requests and responses) occurs within CTA Tracking system

* Manage/liaise with CROs as required

For more information on this position, please reply to this advert or contact Richard Williamson

Lawrence Harvey is acting as an Employment Business in regards to this position.