Senior Country Approval Specialist

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

📋 Description

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

• Provide local regulatory strategy guidance to internal stakeholders.

• Develop and execute the local submission strategy.

• Offer technical expertise and oversight in collaboration with internal departments.

• Act as the primary liaison for investigators and local regulatory bodies.

• Ensure compliance with regulatory guidelines and processes for both internal and external communications.

• Serve as the key country-level contact for submission-related activities.

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

• Coordinate site start-up activities with internal functional departments and established timelines.

• Ensure submission processes are in line with the critical path for site activation.

• Meet company target cycle times for site activations.

• Prepare packages for regulatory compliance review.

• Coordinate local submission activities per the global project submission strategy.

• Develop country-specific Patient Information Sheet/Informed Consent Form documents.

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

• Identify local out-of-scope contractual activities and advise relevant functions accordingly.

• Support feasibility assessments.

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

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

• Stay informed about PPD SOPs, client SOPs/directives, and applicable regulatory guidelines.

• Direct or mentor other Start-Up personnel as necessary.

• Identify, resolve, or escalate issues within the regulatory process.

⛳️ Requirements

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

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

• Consideration may be given to equivalent combinations of appropriate education, training, and/or directly related experience.

• Strong oral and written communication skills.

• Excellent interpersonal capabilities.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

• Good computer skills and the ability to learn relevant software quickly.

• Proficient English language and grammar skills.

• Strong judgment and decision-making abilities.

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

• Ability to work effectively in a team environment or independently, with minimal supervision.

• Capacity to mentor fellow Start-Up team members.

• Excellent team player with team-building abilities.

• Strong organizational and planning skills.

• Knowledge of applicable regional/national regulatory guidelines and EC regulations.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Commitment to scientific excellence.