Senior/Principal Country Approval Specialist

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

📋 Description

• Prepare, review, and manage local regulatory submissions.

• Offer local regulatory strategy guidance to internal stakeholders.

• Design and execute local submission strategies.

• Act as the main point of contact for investigators.

• Ensure adherence to guidelines and processes for effective communication within the team.

• Serve as the primary contact at the country level for all activities related to submissions.

• Participate in Submission Team Meetings, Review Meetings, and Project Team meetings.

• Collaborate with internal functional departments to guarantee alignment in the submission process.

• Meet the company’s target cycle times for site activations.

• Prepare packages for regulatory compliance reviews.

• Stay updated on PPD SOPs, Client SOPs/directives, and current regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic or vocational qualifications.

• Prior experience (2+ years for Senior level or 5+ years for Principal level) in a CRO/Sponsor environment.

• Strong oral and written communication abilities.

• Exceptional interpersonal skills.

• High attention to detail.

• Proficient negotiation skills.

• Solid computer skills.

• Proficient English language and grammar skills.

• Good judgment and decision-making capabilities.

🏝️ Benefits

• Standard work schedule (Monday to Friday).

• Opportunities for professional development.