The Country Approval Specialist is responsible for preparing, reviewing and coordinating, 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.

 Main activities are:
  • 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 WPDs or applicable client SOPs
  • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Qualifications

  • Bachelor’s degree
  • 0 – 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
  • Fluency in English and either Dutch or French
  • 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
What we offer:
  • Our customer hires only the best, develops ourselves and each other, and recognises the power of being one team. They understand that you will want to grow both professionally and personally throughout your career, and therefore at this customer you will benefit from an award-winning learning and development program, ensuring you reach your potential.
  • As well as being rewarded a competitive salary, our customer offers a benefits package based around the health and well-being of our employees.
  • Our customer has a flexible working culture, where they truly value a work-life balance. They have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. They are know as a global organisation but with a local feel.
Apply here