Senior Country Approval Specialist

About the Role

Thermo Fisher Scientific is seeking a Senior Country Approval Specialist to join our team in Saudi Arabia. This full-time role involves managing the preparation, review, and coordination of country submissions in alignment with global submission strategies. The specialist will play a key role in ensuring regulatory compliance and timely site activations.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions (MoH, EC, and other special national applications such as gene therapy approvals, viral safety dossiers, import licenses) in line with global submission strategy.
• Provide regional regulatory strategy advice (MoH and/or EC) to internal clients.
• Develop and implement local submission strategies, offering technical expertise and coordination oversight for projects in collaboration with internal departments.
• Serve as the primary contact for investigators and local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure timely submission management.
• Ensure adherence to guidelines and processes for effective internal team communications, as well as communications with investigators and country regulatory authorities.
• Act as a key country-level contact for all submission-related activities and participate in Submission Team, Review, and Project Team Meetings as required.
• Coordinate with internal functional departments to align site start-up activities with submission activities and agreed timelines, ensuring alignment with the critical path for site activation.
• Achieve company target cycle times for site activations and prepare regulatory compliance review packages as applicable.
• Liaise locally within SIA to ensure local submission activity is planned and delivered according to the global project submission strategy.
• Develop country-specific Patient Information Sheet/Informed Consent form documents.
• Assist with grant budget(s) and payment schedule negotiations with sites, and identify local out-of-scope activities in contracts.
• Support the coordination of feasibility activities in accordance with agreed timelines.
• Ensure trial status information related to SIA activities is accurately maintained and current in the database.
• Oversee country study files to ensure compliance with PPD WPD’s or client SOPs.
• Maintain knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines relevant to services provided.
• Direct and mentor other SIA individuals assigned to support projects, and proactively identify and resolve or escalate issues or anomalies in the regulatory process.

Qualifications and Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 3+ years. An equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, may be considered.

Required Skills and Abilities

• Excellent knowledge of SFDA and all applicable regional/national country regulatory guidelines and EC regulations.
• Effective oral and written communication skills, with excellent interpersonal skills.
• Strong attention to detail and quality of documentation.
• Good negotiation skills and computer proficiency, with the ability to learn new software.
• Fluent Arabic and good English language and grammar skills.
• Good judgment and decision-making skills.
• Basic medical/therapeutic area and medical terminology knowledge.
• Ability to work effectively in a team environment or independently with minimal supervision.
• Ability to mentor fellow SIA team members in a positive and effective manner.
• Excellent team player with strong team-building skills.
• Basic organizational and planning skills.

Company Culture

Joining Thermo Fisher Scientific means becoming part of a global team that values passion, innovation, and a commitment to scientific excellence. The work environment fosters collaboration and development, where individual contributions are recognized.

Application Process

Apply today to contribute to scientific breakthroughs.