Country Approval Specialist at Pharmaceutical Product Development (PPD)

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 
• Coordinate, 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 
• 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, part of Thermo Fisher Scientifics WPDs or applicable client SOPs 
• Maintain knowledge of and understand internal SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided 

Job Qualification

To be considered for the role of Country Approval Specialist you should have: 

Bachelor's degree 

• 2 years related experience or equivalent combination of education, training, & experience 
• Effective oral and written communication skills 
• Excellent interpersonal skills 
• Strong attention to detail and quality of documentation 
• Good negotiation skills 
• Good computer skills and the ability to learn appropriate software 
• Excellent English language skills
• Basic medical/therapeutic area and medical terminology knowledge 
• Ability to work in a team environment or independently, under direction, as required 
• Basic organizational and planning skills 
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation