Senior Country Approval Specialist

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

📋 Description

• Prepare, assess, and manage local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategic advice to internal stakeholders.

• Formulate and execute local submission strategies.

• Provide technical expertise and oversight coordination with internal departments.

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

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

• Serve as the primary country-level liaison for submission-related tasks.

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

• Coordinate site initiation activities with internal functional departments and submission timelines.

• Meet company target cycle times for site activations.

• Prepare regulatory compliance review packages.

• Organize local submission activities in line with global project strategies.

• Develop country-specific Patient Information Sheets and Informed Consent forms.

• Assist in grant budgets and payment schedule negotiations.

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

• Support feasibility assessments.

• Maintain precise and up-to-date trial status data in the database.

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

• Keep abreast of 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 an equivalent and relevant formal academic/vocational qualification.

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

• Proficient oral and written communication skills.

• Strong interpersonal abilities.

• Keen attention to detail and quality of documentation.

• Competent negotiation skills.

• Proficient computer skills and capacity to learn relevant software.

• Good command of the English language and grammar.

• Sound judgment and decision-making capabilities.

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

• Ability to function effectively in a team setting or independently, with minimal supervision.

• Capability to mentor fellow SIA team members.

• Basic organizational and planning skills.

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

• Ability to adapt to office/laboratory and/or clinical environment working conditions, including potential exposure to biological fluids and infectious organisms.

• Capacity to utilize required personal protective equipment.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Exposure to passion, innovation, and scientific excellence.