Senior Regulatory Affairs Specialist - GCL

Senior Regulatory Affairs Specialist - GCL

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Overview

As a senior contact within the Middle East Clinical Operations at CRG, Thermo Fisher Scientific, you will provide regulatory expertise and strategic intelligence to support product development from preclinical stages through registration and product optimization, ensuring compliance with regulatory bodies in the Middle East. You will prepare client deliverables that meet current local, regional, and ICH regulatory and technical requirements and liaise with internal and external clients to deliver specialized regulatory services.

Responsibilities

• Prepare and review regulatory submissions.
• Provide regulatory strategy and / or technical advice to internal and external clients, and act as a liaison in executing strategies.
• Lead the development and implementation of project-specific processes for sponsors.
• Collaborate with other departments, regulatory consultants, and regulatory authorities.
• Identify out-of-scope activities in contracts and coordinate with other departments to handle contract modifications.
• Provide training and guidance to junior team members as appropriate.
• Participate in project launch meetings, review meetings, and project team meetings.
• Support business development activities, including project budgeting and forecasting.

Qualifications

Mandatory Requirements

Knowledge, Skills, and Abilities

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. The role may include travel and requires the ability to communicate effectively with diverse groups and work under pressure while managing multiple projects.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific supports career development and offers an innovative work culture grounded in integrity, intensity, involvement, and innovation.

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