Senior Country Approval Specialist

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

📋 Description

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

• Offer local regulatory strategy guidance to internal stakeholders.

• Develop and execute the local submission strategy.

• Provide technical expertise and coordination oversight in collaboration with internal departments.

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

• Ensure adherence to submission guidelines, processes, and communications.

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

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

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

• Meet company target cycle times for site activations.

• Prepare regulatory compliance review packages.

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

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

• Assist with grant budgets and negotiations regarding site payment schedules.

• Identify out-of-scope contract activities and inform relevant functions.

• Support feasibility activities.

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

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

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

• Direct or mentor SIA team members assigned to projects.

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

⛳️ Requirements

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

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

• A combination of relevant education, training, and/or directly related experience may be deemed equivalent.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Good computer proficiency and the ability to learn necessary software.

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

• Capability to work effectively in a team or independently with minimal supervision.

• Ability to mentor other SIA team members.

• Strong team player with team-building capabilities.

• In-depth knowledge of relevant regional/national regulatory guidelines and EC regulations.

🏝️ Benefits

• Comprehensive health and well-being benefits.

• Wellness programs.

• Employee Assistance Program offering confidential personal and work-related support.

• Flexible work arrangements.

• Generous leave policies.

• Option to purchase additional leave.

• Paid birthday leave.

• Company-paid parental leave.

• Paid volunteer time for charitable organizations.

• Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning.

• Workshops and mentorship programs.

• Opportunities for learning and skill development.