Sr Manager, Regulatory Affairs at Thermo Fisher Scientific

St Louis, Missouri, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechIndustries

Requirements

Bachelor’s degree in a scientific or related field
10+ years in a Quality role in a cGMP environment
5+ years managing people
5+ years regulatory experience in the biopharmaceutical industry
Strong understanding of global regulatory requirements
Highly effective verbal and written communication skills
Collaborative team member with strong communication abilities
Outstanding leadership and collaboration skills
Proven ability to manage staff and regulatory processes
Dedication to achieving flawless compliance
Must be legally authorized to work in the United States now and in the future, without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Ability to work in office and laboratory settings, requiring occasional travel and adherence to safety protocols

Responsibilities

Serve as the primary contact for Site Regulatory Affairs
Coordinate regulatory assessments and filing management
Provide strategic regulatory support to project teams

Skills

Regulatory Affairs

cGMP

Global Regulatory Requirements

Staff Management

Compliance

Quality Management

Project Management

Leadership

Communication Skills

Filing Management

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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