Regulatory Sciences Clinical Trials Manager

CK Group are recruiting for a Regulatory Sciences Clinical Trials Manager to join a global pharmaceutical company, based in the Uxbridge on a contract basis for 12 months.

Salary:

• 40.96ph PAYE

Regulatory Sciences Clinical Trials Manager Role:

• Responsible for filing clinical trial applications to the competent regulatory authorities in UK and Ireland, and all following interactions, in line with the company policies and practices, the European Clinical Trial Directive, Clinical Trials Regulation and local legislation.
• Ensure timely actions related to all clinical trials activities (submissions, approvals, substantial amendments, urgent safety measures, end of trials, serious breach, label approval, archiving, updating RIMsystems, local tracking, informing stakeholders etc) are correctly completed and implemented in line with timelines.
• Responsible for timely archiving of regulatory documentation and maintenance of regulatory databases and RIM system (Veeva Vault).• Following receipt of a clinical trial activity assessment, complete assessment in RIM system (Veeva Vault) and within a stated timeline if a local submission is needed.
• Review documentation within timelines after being informed that the core dossier documents are available. If required, request missing documents or updates to the core documents.

Your Background:

• Science degree, preferably medical, pharmaceutical or other life science
• Preferably minimum 5 years experience in (local) clinical trials regulatory affairs in a multinational pharmaceutical company
• Thorough knowledge of EU and local clinical trials related processes
• Knowledge of Good Practices (GMP, GDP, GCP) and quality systems used during stages of manufacture, testing, release, transportations and storage of medicinal products
• Demonstrated ability in planning, problem solving and time management

Company:

Our client is world renowned pharmaceutical company with a mission to discover, develop and deliver innovative medicines to patients with serious diseases.

Location:

This Regulatory Sciences Clinical Trials Manager role will be based at our clients site in Uxbridge.

Apply: For more information, or to apply for this Regulatory Sciences Clinical Trials Manager position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52468.

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