Senior Country Approval Specialist

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

📋 Description

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

• Offer local regulatory strategy insights to internal clients.

• Formulate and execute local submission strategies while providing technical expertise and oversight in coordination.

• Act as the main point of contact for investigators and local regulatory authorities.

• Ensure adherence to guidelines and processes for communications involving internal parties, investigators, and regulatory authorities.

• Serve as the key country-level liaison for activities related to submissions.

• Engage in submission, review, and project team meetings.

• Coordinate site start-up activities with internal departments and align submission schedules with site activation critical paths.

• Meet company target cycle times for site activations.

• Prepare packages for regulatory compliance review.

• Manage local submission activities in alignment with the global project submission strategy.

• Create country-specific Patient Information Sheets and Informed Consent documents.

• Assist in negotiating grant budgets and payment schedules with sites.

• Identify local out-of-scope contract activities and provide guidance to relevant functions.

• Support feasibility assessments.

• Maintain accurate and up-to-date trial status information in the database.

• Supervise country study files to ensure compliance with PPD WPD or client SOPs.

• Keep up to date with PPD SOPs, client SOPs/directives, and current regulatory guidelines.

• Direct or mentor SIA individuals assigned to projects.

• Identify, resolve, or escalate issues and anomalies in the regulatory process.

⛳️ Requirements

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

• Over 5 years of prior experience providing the knowledge, skills, and abilities necessary for the role.

• Combinations of appropriate education, training, and/or directly related experience may also be considered.

• Proficient oral and written communication skills.

• Strong interpersonal abilities.

• Keen attention to detail and quality in documentation.

• Effective negotiation skills.

• Competent computer skills and a willingness to learn relevant software.

• Proficient English language and grammar skills.

• Sound judgment and decision-making abilities.

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

• Capability to work in both team environments and independently with minimal supervision.

• Ability to mentor fellow SIA team members.

• Excellent team player with strong team-building abilities.

• Basic organizational and planning skills.

• Comprehensive knowledge of applicable regional/national country regulatory guidelines and EC regulations.

• Ability to function in an office/laboratory and/or clinical environment.

• Capability to use necessary personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A culture driven by passion, innovation, and a commitment to scientific excellence.

• Experience working within a global team environment.