Senior Regulatory Affairs Specialist GCL

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our colleagues with the resources needed to achieve career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Location/Division Specific Information

Our PPD part of Thermo Fisher Scientific team has a direct impact on improving patient health through the expertise of scientists industry thought-leaders and therapeutic experts. As the world leader in serving science our Clinical Operations professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

Serves as a senior contact within the Middle East Clinical Operations at CRG Thermo Fisher Scientific providing innovative solutions and regulatory expertise. Interacts with clients to offer strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization ensuring compliance with regulatory bodies in the middle east. Provides strategic expedient and efficient preparation of client deliverables that meet current local regional and ICH regulatory and technical requirements. Acts as a liaison with internal and external clients in the provision and marketing of these specialized regulatory services.

A day in the Life:

• Prepares and reviews regulatory submissions.
• Provides regulatory strategy and/or technical advice to internal and external clients and acts as a liaison in executing strategies.
• Leads the development and implementation of project-specific processes for sponsors.
• Collaborates extensively with other departments regulatory consultants and regulatory authorities.
• Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Provides training and guidance to junior team members as appropriate.
• Participates in project launch meetings review meetings and project team meetings.
• Supports business development activities including project budgeting/forecasting

Keys to Success:

Mandatory requirements

• Saudi Arabia National

• Native Arabic speaker

• Willingness to be based in Riyadh

Knowledge Skills Abilities

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 3 years).
• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Strong English language (written and oral) communication skills as well as local language where applicable
• Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization licensing lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas such as preclinical clinical CMC publishing etc.
• Solid understanding of medical terminology statistical concepts and guidelines
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Solid attention to detail and quality as well as strong editorial/proofreading skills
• Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Solid computer skills including the use of Microsoft Word Excel Power Point; capable of learning new technologies
• Solid organizational time management and planning skills to create and follow timelines conduct long-range planning adapt to changing priorities and handle multiple projects
• Solid negotiation skills
• Strong analytical investigative and problem-solving skills
• Working knowledge of budgeting and forecasting

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!