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Thermo Fisher Scientific · 12 hours ago

Regulatory Affairs Specialist III

Greenville, NC

Full-time

Onsite

Mid Level

3+ years exp

Thermo Fisher Scientific is dedicated to enabling customers to make the world healthier, cleaner, and safer. As a Regulatory Affairs Specialist III, you will support regulatory aspects of customer projects and ensure compliance with applicable regulations, while collaborating on various regulatory submissions and strategic projects.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

H1B Sponsor Likely

Responsibilities

Contribute to authoring, review and provide comments for Chemistry Manufacturing and Control (CMC) CTD documents, including Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers, per the North American Regulatory Affairs Services Menu

Collaborate and coordinate with SMEs to support the authoring and review activities of CMC CTD documents

Prepare company regulatory submissions (e.g. site master files, drug master files)

Support key company projects in the North America region such as new facilities, new strategic customers

Contribute to moderately complex regulatory strategic advice for internal customers and clients

Contribute to the maintenance of centralized records for compliance status of North American manufacturing sites

Participate in regulatory impact evaluation of change controls

Track NA Regulatory Services metrics for self-assist with collation and reporting out for North American network

Contribute to regulatory intelligence surveillance and communication to the network

Qualification

Regulatory experienceCGMPQuality systems expertiseASQ certificationsFDA regulationsOrganizational skillsVerbal communication skillsWritten communication skillsNegotiation skillsTeam player

Required

Bachelor's degree in a scientific or related field is required

3-4 years of regulatory experience in the pharmaceutical industry

Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)

Expertise in quality systems including: CAPA and deviation management, change control, risk management and FMEA, document control, and internal/external auditing

Preferred

Advanced Degree preferred

Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field

ASQ certifications (CQE, CQA) desired

Company

Thermo Fisher Scientific

Glassdoor3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10001+ employees

https://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (272)

2024 (224)

2023 (233)

2022 (342)

2021 (315)

2020 (227)

Funding

Current Stage

Public Company

Total Funding

$15.97B

Key Investors

National Grid

2025-11-24Post Ipo Debt· $2.42B

2025-09-30Post Ipo Debt· $2.5B

2023-08-07Post Ipo Debt· $2.95B

Leadership Team

Stephen Williamson

Senior Vice President and Chief Financial Officer

Michel Lagarde

Chief Operating Officer

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Company data provided by crunchbase