Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries
Requirements
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the local clinical trials landscape in Argentina
- Good command of the English language (written and oral) as well as local language
- Excellent attention to detail and quality, as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects
- Excellent understanding of national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative, and problem-solving skills
Responsibilities
- Preparation and assembly of local regulatory submissions in Argentina
- Interact with sponsors based on each case
- Review and assess clinical trial regulatory documents
- Review and assess scientific literature
- Participate in launch meetings, review meetings, and project team meetings
- Lead discussions and coordinate regulatory strategies in Argentina on Phase 1 to 4 clinical trials, studies, and projects
- Provide regulatory advice and carry out projects in the provision of regulatory affairs services
- Act as liaison with internal and external clients
- Act as a representative of the regulatory department in Argentina with other departments
- Support business development, work on initiatives, and contribute to quality improvement
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work location and schedule for this position?
The role is based in the Regulatory Affairs department in Argentina with a standard Monday-Friday work schedule in an office environment.
What salary or compensation does this role offer?
This information is not specified in the job description.
What key skills are required for the Senior Regulatory Affairs Specialist role?
Required skills include preparation and assembly of local regulatory submissions in Argentina, knowledge of national country requirements for clinical trial authorization, excellent English and local language command, exceptional interpersonal skills, and strong organizational and analytical abilities.
What is the team environment like at Thermo Fisher Scientific for this role?
The role involves working as a pivotal team member in the Regulatory Affairs department, participating in launch meetings, review meetings, and project team meetings, with exceptional interpersonal skills needed to collaborate effectively and act as a liaison with other departments.
What qualifications make a strong candidate for this position?
A Bachelor's degree or advanced degree preferred, previous experience in regulatory affairs for clinical trials, knowledge of the local clinical trials landscape in Argentina, and expert knowledge of national requirements and ICH guidelines are key to standing out.
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Risks
Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.
Differentiation
Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.
Upsides
Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.
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