Country Approval Specialist

Proclinical is advertising a vacancy for a Country Approval Specialist position with an international contract research organisation. The company, which provides drug discovery, lifecycle management, and laboratory services, is seeking for a driven and talented individual to join their company in a home-based capacity. This is an exciting opportunity to work with a company that provides innovative ideas behind multiple pharmaceutical sectors.

Job Responsibilities:

• Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provide project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPDs target cycle times for site May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Skills and Requirements:

• Bachelor's degree.
• Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations.
• Demonstrable project management skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Julia Tegelmann at +44 203 854 1052 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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