Senior Regulatory Affairs Specialist - Central Labs
Senior Regulatory Affairs Specialist - Central Labs
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving complex analytical challenges improving patient diagnostics and therapies or increasing efficiency in their laboratories we are here to support them. Our team of more than 100000 colleagues delivers an unrivaled combination of innovative technologies purchasing convenience and pharmaceutical services through our industryleading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD. For more information please visit .
Group/Division Summary:
Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists industry thoughtleaders and therapeutic experts. As the world leader in serving science our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations
Discover Impactful Work:
Serves as a senior contact within the Global Central Labs at CRG Thermo Fisher Scientific providing innovative solutions and regulatory expertise. Interacts with clients to offer strategic regulatory intelligence and guidance ensuring compliance with FDA/IVDR CE regulations as well as CAP and CLIA standards. 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 laboratory services.
A day in the Life:
- Prepares and reviews regulatory guidance.
- 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 projectspecific processes for sponsors.
- Collaborates extensively with other departments regulatory consultants and regulatory authorities.
- 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 to advise on regulatory implications for project delivery
Keys to Success:
Education
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
Experience
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).
Knowledge Skills Abilities
- Strong English language (written and oral) communication skills as well as local language where applicable
- 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 longrange planning adapt to changing priorities and handle multiple projects
- Solid negotiation skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- 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 specialty areas such as preclinical clinical CMC publishing etc.
- Solid understanding of medical terminology statistical concepts and guidelines
- Strong analytical investigative and problemsolving 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.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
Senior IC
Employment Type
Full-Time
