Senior Country Approval Specialist

Role Overview

Join our team as a Senior Country Approval Specialist to play a pivotal role in managing and coordinating the preparation and review of regulatory submissions aligned with a global strategy. This position is based onsite in Saudi Arabia at Thermo Fisher Scientific, operating in standard office conditions from Monday to Friday.

Key Responsibilities

• Coordinate and prepare local regulatory submissions including Ministry of Health and ethics committees, as well as special local applications such as gene therapy approvals, viral safety dossiers, and import licenses, ensuring alignment with the global submission framework.
• Advise internal stakeholders on regional regulatory strategies involving the Ministry of Health and Ethics Committees.
• Develop local submission plans and provide expert technical guidance for project coordination alongside internal departments.
• Serve as the main liaison with investigators and local regulatory bodies, ensuring timely management of submissions and resolving complex matters in collaboration with the local regulatory manager.
• Ensure adherence to guidelines and processes for clear communication within teams, with investigators, and with local regulatory authorities.
• Act as the principal contact for all submission-related activities at the country level and actively engage in submission, review, and project team meetings.
• Coordinate with internal teams to synchronize site start-up activities with submission timelines, maintaining alignment with critical paths for site activation and achieving target cycle times.
• Prepare regulatory compliance review packages where applicable and ensure submissions meet corporate standards.
• Collaborate with local SIA teams to align submission activities with global project strategies.
• Develop localized Patient Information Sheets and Informed Consent forms.
• Assist with grant budget assessments and negotiate payment schedules with study sites as necessary.
• Identify non-standard local activities in contracts and advise appropriate functions promptly.
• Support feasibility assessments to ensure they are completed according to schedule.
• Maintain up-to-date trial status information in databases and oversee country study files to ensure compliance with SOPs.
• Stay informed on corporate and client SOPs, regulatory guidelines, and directives relevant to services delivered.
• Provide mentorship to assigned SIA team members, addressing challenges proactively and escalating issues as needed.

Qualifications and Experience

• Bachelor's degree or equivalent academic/vocational qualification.
• At least three years of relevant experience offering requisite knowledge, skills, and abilities for the role. Equivalent education, training, and related experience combinations will also be considered.

Skills and Competencies

• In-depth knowledge of Saudi Food & Drug Authority (SFDA) and regional/national regulatory and ethics committee guidelines.
• Strong oral and written communication abilities in both Arabic (fluent) and English (good proficiency).
• Excellent interpersonal skills with attention to detail and high documentation quality.
• Negotiation expertise and proficient computer literacy with adaptability to new software tools.
• Good judgment and decision-making capacity, basic medical and therapeutic knowledge, and familiarity with medical terminology.
• Ability to work independently or as part of a team with minimal supervision and mentor colleagues constructively.
• Organizational skills, team-building aptitude, and effective planning capabilities.

Working Conditions

Standard Monday to Friday schedule in an office environment.

Why Thermo Fisher Scientific?

Joining our company means becoming part of a global team dedicated to innovation, passion, and scientific excellence. We foster collaboration and personal development in a workplace where your impact leads to meaningful scientific advancements.