Regulatory Affairs Specialist I (Admin) at Thermo Fisher Scientific

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

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 1 to 3 years)
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
Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Good analytical, investigative and problem-solving skills
Capable of interpreting data

Responsibilities

Perform global regulatory compliance review of essential documents supporting the customization of study-specific Essential Document Checklists
Respond to project teams on queries on Essential Document Checklist requirements
Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams
Ensure effective management and coordination of the Essential Document Checklist Process
Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
Responsible for reviewing, finalizing and posting of the Essential Document Checklists
Other duties as required

Skills

Regulatory Compliance

Essential Document Checklists

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

English Communication

Attention to Detail

Regulatory Affairs

Clinical Trial Authorization

SOP Management

Analytical Skills

Problem-Solving

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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