Senior Regulatory Affairs Specialist - GCL

Senior Regulatory Affairs Specialist - GCL

Join to apply for the Senior Regulatory Affairs Specialist - GCL role at Thermo Fisher Scientific. 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

Saudi Arabia National Native Arabic speaker Willingness to be based in Riyadh Knowledge, Skills, and Abilities

3+ years of relevant experience or equivalent Bachelor's degree or equivalent and relevant formal qualification Strong English language communication skills; proficiency in local language where applicable Understanding of global / regional / national regulatory requirements for clinical trial authorization, licensing, lifecycle management; knowledge of ICH and global regulatory guidelines; familiarity with regulatory specialty areas (preclinical, clinical, CMC, publishing, etc.) Medical terminology, statistical concepts, and guidelines Ability to work independently and assess sponsor regulatory needs to produce compliant deliverables Attention to detail, strong editorial / proofreading skills Strong interpersonal skills and ability to collaborate across departments Computer proficiency with Microsoft Word, Excel, PowerPoint; ability to learn new technologies Strong organizational and time management skills; ability to manage timelines and multiple projects Negotiation skills Analytical, investigative, and problem-solving abilities Working knowledge of budgeting and forecasting 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. Able to communicate information and ideas with diverse groups Able to work upright and stationary for typical working hours Proficient with standard office equipment and technology Able to perform under pressure while prioritizing and handling multiple projects May require travel 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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