Senior Country Approval Specialist

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

📋 Description

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

• Offer local regulatory strategy guidance to internal clients.

• Design and execute local submission strategies.

• Provide technical expertise and oversee coordination in partnership with internal departments.

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

• Ensure adherence to guidelines and processes for communications with internal teams, investigators, and regulatory authorities.

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

• Engage in Submission Team, Review, and Project Team meetings.

• Coordinate site initiation activities with internal functional departments and align submission timelines with the critical paths for site activation.

• Meet target cycle times for site activations.

• Prepare regulatory compliance review packages.

• Coordinate local submission efforts in line with the global project submission strategy.

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

• Assist in negotiating grant budgets and site payment schedules.

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

• Support feasibility assessments.

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

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

• Stay informed of PPD and client SOPs/directives as well as relevant regulatory guidelines.

• Direct or mentor SIA team members involved in assigned projects.

• Identify, resolve, or escalate issues and anomalies related to regulatory processes.

⛳️ Requirements

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

• A minimum of 5 years of previous experience providing the knowledge, skills, and abilities necessary for the role.

• Relevant education, training, and/or directly related experience may be considered as an equivalency.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

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

• 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 work both in a team and independently with minimal supervision.

• Capacity to mentor fellow SIA team members.

• Excellent team player with strong teambuilding skills.

• Basic organizational and planning skills.

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

• Ability to work in an office, laboratory, and/or clinical environment.

• Potential exposure to biological fluids and infectious organisms.

• Personal protective equipment is required, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Collaborative global team environment.

• Opportunities for collaboration and professional development.

• Workplace focused on scientific excellence.

• Provision of personal protective equipment such as protective eyewear, garments, and gloves.