Country Approval Specialist (EMEA)

A multinational full-service CRO is seeking a Country Approval Specialist (EMEA) to join their team in Lisbon, Portugal on a contract basis.

Job Role:

• The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

Role 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 company 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 company 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 company WPDs or applicable client SOPs
• Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Education and Experience:

• Bachelor's degree
• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation

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 call Andrea on +44 203 854 0675 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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