Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our general team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions and local site activation in line with the global start up strategy. As a Country Approval Specialist, you'll play a key role in ensuring that site activations are managed effectively and align with our strategic goals.
What You’ll Do:
- Prepares, reviews and coordinates 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.
- Provides local regulatory strategy advice (MoH &/or EC) to internal clients.




- Provides project specific local SIA services and coordination of these projects.
- Contact investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates 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.
- Leads local strategy and oversight of internal local team towards expedited site activation.
- Achieves PPD’s target cycle times for site.
- Work with the clinical team to prepare the regulatory compliance review packages, as applicable.
- Develop country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Enters and

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