Country Approval Specialist

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Prepare, review, and coordinate local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategy guidance to internal clients under supervision.

• Provide and manage project-specific local SIA services.

• Engage with investigators for activities related to submissions as necessary.

• Act as the primary country-level contact for ethical or regulatory submission activities.

• Collaborate with internal functional departments on site start-up activities and submission schedules.

• Meet target cycle times for sites.

• Work alongside start-up CRAs to develop regulatory compliance review packages as needed.

• Create country-specific Patient Information Sheet/Informed Consent documents as required.

• Assist in negotiations regarding grant budgets and payment schedules with sites.

• Support feasibility activities in accordance with established timelines.

• Input and update trial status information in tracking databases.

• Prepare, establish, and maintain local country study files and filing procedures.

• Stay informed about PPD and client SOPs/directives as well as current regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Prior experience totaling at least 2 years in a comparable role.

• Strong oral and written communication abilities.

• Exceptional interpersonal skills.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills and ability to learn necessary software.

• Proficient English language and grammar skills.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Capability to work either collaboratively within a team or independently, as needed.

• Basic organizational and planning abilities.

• Foundational knowledge of relevant regional/national country regulatory guidelines and EC regulations.

• Equivalency may include a blend of appropriate education, training, and/or directly related experience.

🏝️ Benefits

• Competitive salary package.

• Comprehensive health and wellness programs.

• Opportunities for professional development and growth.

• Flexible working arrangements.