Principal Country Approval Specialist (Startup Lead)
Core
Manages the preparation, review, and coordination of local regulatory submissions for clinical trials in alignment with global strategy.
Role type
Senior IC regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and country study files for clinical trial activations
Domain
Life sciences / Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
Local regulatory strategy, regulatory submission coordination, stakeholder management with authorities, project timeline alignment, contract scope identification, SOP compliance, mentorship
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, digital literacy
Technologies
PPD regulatory intelligence systems, database management tools
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, gene therapy, viral safety dossiers); Provide local regulatory strategy advice to internal clients; Serve as primary contact for investigators and local regulatory authorities; Coordinate with start-up CRAs for compliance review packages; Develop country-specific Patient Information Sheets and Informed Consent forms; Maintain accurate trial status information in the database; Mentor other SIA team members.
Seniority
Senior, hands-on IC with mentorship responsibilities
