Regulatory Affairs Specialist I at Thermo Fisher Scientific

Loughborough, England, United Kingdom

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Scientific Instruments, Regulatory AffairsIndustries

Requirements

  • Expertise in regulatory compliance and risk assessment for new products
  • Ability to collaborate with cross-functional teams (procurement, logistics, sales, business development)
  • Strong communication skills to provide insights and address queries
  • Capability to monitor regulatory changes and industry trends
  • Experience in supplier evaluation and relationship building based on compliance track record

Responsibilities

  • Maintain and refine efficient processes for new item creation and prioritize agility in compliance checks for timely product inclusion
  • Collaborate with business development and procurement teams to align compliance with strategic portfolio expansion goals and provide insights for new product acquisitions
  • Work closely with suppliers to accelerate compliance verification, evaluate them, and establish positive relationships
  • Monitor regulatory landscape and industry trends impacting new products, proactively communicating insights to internal teams
  • Conduct detailed risk assessments for new products, provide risk mitigation strategies, and mentor on informed decision-making
  • Facilitate effective cross-functional collaboration and communication to address compliance-related queries and challenges

Skills

Key technologies and capabilities for this role

Regulatory ComplianceRisk AssessmentSupplier ManagementPortfolio PlanningCross-Functional CollaborationRegulatory MonitoringCompliance EvaluationBusiness Development

Questions & Answers

Common questions about this position

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

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

What are the key responsibilities for this Regulatory Affairs Specialist role?

Key responsibilities include maintaining agile compliance processes for new products, collaborating with business development and suppliers, monitoring regulatory changes, conducting risk assessments, and working cross-functionally with teams like procurement and sales.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like at Thermo Fisher Scientific for this role?

The role involves working with a world-class team in a collaborative environment focused on scientific innovation, compliance excellence, and cross-functional partnerships to drive portfolio expansion.

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

Strong candidates will have expertise in regulatory compliance, experience with risk assessments and supplier evaluation, and the ability to collaborate across functions while staying proactive on regulatory trends.

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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