Ctry Approval Spec

Work Schedule

Environmental Conditions

Job Description

• Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy;

• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;

• 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 PPD’s 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;

• Enters and maintains trial status information relating to start up activities onto PPD tracking databases in an accurate and timely manner;

• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs;

• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves