[Remote] Sr. Manager of Regulatory Affairs, Biologicals and Chemicals at Thermo Fisher Scientific

New York, New York, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, ChemicalsIndustries

Skills

Key technologies and capabilities for this role

Regulatory AffairsPharmaceuticalsBiologicalsChemicalsDrug Support StrategyAncillary MaterialsExcipientsGMPCMC DocumentationGlobal RegulationsComplianceLeadershipCross-functional Collaboration

Questions & Answers

Common questions about this position

Is this position remote, and what are the location requirements?

This is a remote position available for hire in the USA or Scotland, with residency in the US or Scotland required. No relocation assistance will be provided.

What education and experience are required for this role?

A Bachelor's Degree in Pharmaceutical Sciences, Chemistry, or related field is required (advanced degree preferred), along with 7 years of experience in CMC regulatory affairs within the pharmaceutical industry and 1+ year of prior experience leading a successful team of direct reports.

What is the salary or compensation for this position?

This information is not specified in the job description.

What are the main responsibilities of this role?

The role involves providing strategic regulatory leadership for pharmaceutical ancillary materials and excipients, developing drug support strategies, leading regulatory affairs talent, collaborating with cross-functional teams, and ensuring compliance with global regulations.

What makes a strong candidate for this Sr. Manager position?

Candidates with a strong background in pharmaceutical regulatory operations, experience leading teams, and the ability to interpret global regulations and develop scalable strategies will 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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