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

Key technologies and capabilities for this role

Regulatory AffairscGMPGlobal Regulatory RequirementsStaff ManagementComplianceQuality ManagementProject ManagementLeadershipCommunication SkillsFiling Management

Questions & Answers

Common questions about this position

What benefits are offered for this position?

The company offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits, along with outstanding career and development prospects.

Is this role remote or office-based?

The role is based in St. Louis, Missouri, in office and laboratory settings, with a standard Monday-Friday schedule and occasional travel required.

What experience and skills are required for this Sr Manager role?

Candidates need a Bachelor’s degree in a scientific field, 10+ years in a Quality role in a cGMP environment, 5+ years managing people, 5+ years regulatory experience in biopharma, strong understanding of global regulatory requirements, and outstanding leadership and communication skills.

What is the company culture like at Thermo Fisher Scientific?

The company culture stands for integrity, intensity, involvement, and innovation, within an innovative, forward-thinking organization.

What should I know before applying for this Sr Manager role?

Candidates must be legally authorized to work in the US without sponsorship, able to pass a comprehensive background check including drug screening, and relocation assistance may be provided; highlight your 10+ years Quality experience in cGMP, regulatory expertise, and leadership in managing teams.

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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