Principal Reg Affairs Assistant at Thermo Fisher Scientific

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Life SciencesIndustries

Requirements

Bachelor's or Master’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+ years)

Responsibilities

Supports the preparation of documentation and submissions under EUCTR 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
Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
Evaluates client needs in relationship to overall project timelines, quality and delivery
Engages with 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 project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients
Supports preparation of bids and proposals; generates, tracks and analyses data for proposal, revisions, contract modifications and bid defenses

Skills

Key technologies and capabilities for this role

EUCTRRegulatory ComplianceSOPsProject CoordinationClient LiaisonDocumentation PreparationProject ManagementBid PreparationData Analysis

Questions & Answers

Common questions about this position

What education and experience are required for the Principal Reg Affairs Assistant role?

A Bachelor's or Master’s degree or equivalent formal academic/vocational qualification is required, along with previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 1+ years.

Is this a remote position, or is office work required?

The role is based in office environmental conditions with a standard Monday-Friday work schedule.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the work environment or company culture look like at Thermo Fisher Scientific for this role?

This information is not specified in the job description.

What makes a strong candidate for this Principal Reg Affairs Assistant position?

Candidates with a Bachelor’s or Master’s degree, at least 1+ years of relevant experience, knowledge of EUCTR guidance, SOPs, regulatory guidelines, and strong coordination skills for project management and client deliverables stand 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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