Senior Country Approval Specialist

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

📋 Description

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

• Offer local regulatory strategy guidance to internal stakeholders

• Formulate and execute the local submission strategy

• Provide technical expertise and oversight for project coordination

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

• Ensure compliance with regulatory guidelines, processes, and communication protocols

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

• Participate in submission, review, and project team meetings

• Coordinate site initiation activities with internal departments

• Meet target cycle times for site activations

• Prepare packages for regulatory compliance reviews

• Align local submission activities with the global project submission strategy

• Create country-specific Patient Information Sheets and Informed Consent forms

• Assist in negotiating grant budgets and payment schedules

• Identify local out-of-scope contract activities and provide advice 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 SOPs

• Stay informed about company, client, and regulatory requirements

• Direct or mentor SIA team members

• Identify, resolve, or escalate issues related to regulatory processes

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic/vocational training

• Prior experience equivalent to 5+ years

• Strong oral and written communication abilities

• Excellent interpersonal skills

• High attention to detail and quality in documentation

• Proficient negotiation skills

• Competent computer skills with the ability to learn necessary software

• Proficient English language skills and grammar

• Sound judgment and decision-making capabilities

• Basic understanding of medical/therapeutic areas and medical terminology

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

• Ability to mentor fellow SIA team members

• Basic organizational and planning abilities

• Comprehensive knowledge of relevant regional/national regulatory guidelines and EC regulations

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

🏝️ Benefits

• Fully remote work

• Standard office hours (40 hours/week)

• Opportunities for global team collaboration and professional development