[Remote] Regulatory Affairs Specialist at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical TrialsIndustries

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 and global clinical trials landscape
Excellent command of the English language (written and oral) as well as local language where applicable
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
Capable of working independently on assigned tasks
Good understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; knowledge of ICH and other global regulatory guidelines
Excellent analytical, investigative, and problem-solving skills

Responsibilities

Support the preparation and compilation of local regulatory submissions to ANVISA related to the clinical development dossier and clinical trial applications for drugs, biologics, advanced therapies, and devices
Interact with sponsors, internal teams, and regulatory agencies
Review and assess clinical trial regulatory documents
Enter and maintain trial status information relating to RA activities onto PPD tracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are maintained as per PPD WPDs or applicable client SOPs
Participate in project team meetings
Develop and implement project-specific processes
Attend meetings with local associations and participate in initiatives to foster clinical trials in Brazil
Act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement

Skills

Key technologies and capabilities for this role

ANVISA submissionsclinical trial applicationsregulatory submissionsregulatory documents reviewPPD tracking databasesproject team meetingsEnglish proficiencyPortuguese

Questions & Answers

Common questions about this position

What is the work location and schedule for this Regulatory Affairs Specialist role?

The position is based in Brazil with a standard Monday-Friday work schedule in an office environment.

What qualifications and experience are required for this position?

A Bachelor's degree or advanced degree preferred, or equivalent qualification, along with previous experience providing the knowledge, skills, and abilities to perform the job, and knowledge of the local and global clinical trials landscape are required.

What key skills are needed to succeed in this role?

Required skills include excellent command of English and local language, exceptional interpersonal skills, advanced computer skills with Microsoft Office, strong organizational and time management skills, and knowledge of global regulatory guidelines for clinical trials.

What does the team environment look like for this position?

You will be a pivotal team member supporting local team members within regulatory affairs, working effectively in a team environment, acting as a liaison with other departments, and participating in project team meetings.

What makes a strong candidate for this Regulatory Affairs Specialist role?

Strong candidates will have a relevant degree, prior experience in regulatory affairs for clinical trials, knowledge of ANVISA submissions and global guidelines like ICH, excellent English proficiency, and strong organizational and interpersonal skills to handle multiple projects independently.

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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