[Remote] Regulatory Affairs Specialist at Thermo Fisher Scientific

Mexico

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years); equivalency of appropriate education, training, and/or directly related experience may be considered
Good English language (written and oral) communication skills as well as local language where applicable
Good attention to detail and quality as well as editorial/proofreading skills
Good interpersonal skills to work effectively in a team environment
Good computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies
Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects
Good negotiation skills
Capable of working independently with direction and exercising independent judgment
Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Basic understanding of medical terminology, statistical concepts, and guidelines
Good analytical, investigative, and problem-solving skills
Capable of interpreting data

Responsibilities

Supports the preparation of documentation and submissions under guidance
Coordinates and manages client deliverables supporting regulatory compliance
Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects; assists with project budgeting/forecasting
Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
Assists in business development and pricing of projects for the department
Evaluates client needs in relationship to overall project timelines, quality, and delivery
Engages other project team members, functional units, and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed
Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence and guidance supporting product development from preclinical through registration and product optimization
Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements
Acts as liaison with internal and external clients in the provision and marketing of these services

Skills

Key technologies and capabilities for this role

Regulatory AffairsICH GuidelinesRegulatory SubmissionsSOPsProject ManagementClient LiaisonBusiness DevelopmentProject Budgeting

Questions & Answers

Common questions about this position

What education and experience are required for the Regulatory Affairs Specialist role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Equivalency of appropriate education, training, and/or directly related experience may be considered.

What key skills are needed for this position?

Candidates need good English language (written and oral) communication skills, good attention to detail and quality with editorial/proofreading skills, good interpersonal skills for team environments, and good computer skills including Microsoft Word, Excel, and PowerPoint.

Is this a remote position or does it require office work?

This is an office-based role with standard Monday-Friday scheduling and office environmental conditions.

What is the salary or compensation for this role?

This information is not specified in the job description.

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

Strong candidates will have a Bachelor's degree with 2+ years of relevant experience, excellent communication and interpersonal skills, attention to detail, and proficiency in Microsoft Office tools, enabling them to support regulatory submissions and client deliverables effectively.

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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