Senior Country Approval Specialist

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🕒 May 26

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Manage the preparation, review and coordination of Country Submissions in line with global submission strategy • Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy • Provide regional regulatory strategy advice to internal clients • Develop and implement local submission strategy • Provide technical expertise and coordination oversight for projects • Serve as primary contact for investigators and local regulatory authorities • Ensure guidelines and processes are followed for effective internal team communications • Act as a key-contact at country level for all submission-related activities • Participate in Submission Team Meetings, Review Meetings and Project Team meetings • Coordinate with internal functional departments for site start-up activities • Achieve company’s target cycle times for site activations • Prepare regulatory compliance review packages • Liaise within SIA locally to ensure local submission activity is planned • Develop country specific Patient Information Sheet/Informed Consent form documents • Assist with grant budgets(s) and payment schedules negotiations with sites • Identify and recognize local out of scope activities in a contract in a timely manner • Support the coordination of feasibility activities in accordance with agreed timelines • Ensure accurate maintenance of trial status information relating to SIA activities • Oversee country study files and ensure compliance • Maintain knowledge of and understand PPD SOPs and current regulatory guidelines • Direct/mentor other assigned individuals • Proactively identify issues or anomalies in the regulatory process

🎯 Requirements

• Bachelor's degree or equivalent • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years) • Excellent knowledge of SFDA and all applicable regional / national country regulatory guidelines and EC regulations • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills • Fluent Arabic and Good English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, with minimal supervision, as required • Ability to mentor fellow SIA team members in a positive and effective manner • Excellent team player with teambuilding skills • Basic organizational and planning skills

🏖️ Benefits

• Professional development opportunities