Country Approval Specialist - FSP - EMEA

Role overview

Join a global organization supporting leading pharmaceutical and biotech companies in the planning and coordination of country-level submissions. In this role, you will help prepare, review, and manage regulatory and ethical submission activities so they stay aligned with the overall submission plan and broader study timelines.

The position is based in Saudi Arabia and follows a standard Monday to Friday schedule in an office setting.

The company has supported the top 50 pharmaceutical companies and more than 750 biotech organizations, contributing to 2,700 clinical trials in over 100 countries during the last five years.

Key responsibilities

• Prepare, review, and coordinate local regulatory filings under supervision, including Ministry of Health and Ethics Committee submissions, along with any required special national applications such as gene therapy approvals, viral safety dossiers, and import permits.
• Support internal teams with local regulatory guidance related to Ministry of Health and/or Ethics Committee processes, as needed.
• Provide project-specific local site initiation and approval coordination support.
• Communicate with investigators when submission-related interaction is required.
• Serve as the main country-level contact for ethical or regulatory submission activities.
• Work with internal departments to align site start-up tasks with submission milestones and agreed timelines, keeping study activation on the critical path.
• Help meet target turnaround times for site start-up activities.
• Collaborate with start-up clinical research associates to prepare regulatory compliance review packets where applicable.
• Assist in preparing country-specific patient information sheets and informed consent documents when needed.
• Support discussions around grant budgets and site payment schedules, if required.
• Contribute to feasibility coordination activities according to agreed timelines.
• Enter and update trial status details related to site initiation activities in tracking systems accurately and on time.
• Ensure local study files and filing workflows are created, maintained, and kept current in line with internal work instructions or client SOPs.
• Maintain working knowledge of applicable company SOPs, client procedures, and current regulatory guidance relevant to the service area.

Experience and education

A bachelor’s degree or an equivalent combination of formal academic or vocational qualifications is required. The role typically expects more than 2 years of directly relevant experience, or an equivalent mix of education, training, and related experience.

Skills and abilities

• Clear verbal and written communication
• Strong interpersonal capability
• High attention to detail and documentation quality
• Negotiation skills
• Comfort using computers and learning new software
• Good command of English grammar and language
• Basic understanding of medical or therapeutic areas and medical terminology
• Ability to work both independently and as part of a team under guidance
• Organizational and planning fundamentals
• Working knowledge of regional and national regulatory and ethics committee requirements

Work environment

This role is performed in an office and/or laboratory and/or clinical environment. There may be exposure to biological fluids and potentially infectious organisms, as well as electrical office equipment. Use of personal protective equipment, including protective eyewear, garments, and gloves, may be required.

Schedule

The working pattern is standard Monday to Friday.