[Remote] Sr Reg Affairs Spec at Thermo Fisher Scientific

Argentina

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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

Regulatory Submissions

Clinical Trials

Regulatory Affairs

ANMAT

Clinical Trial Documents

Scientific Literature Review

Project Coordination

English Proficiency

Microsoft Office

Interpersonal Skills

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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