Regulatory Affairs Engineer jobs in United States
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Sterling Engineering · 17 hours ago

Regulatory Affairs Engineer

positionUnited States
timeContract
remoteRemote
seniorityMid Level
date3+ years exp

Sterling Engineering is a global leader in drug delivery and combination products, seeking a Regulatory Affairs Engineer to join their innovative team. The role involves developing and executing CMC strategies, preparing submissions for global applications, and coordinating with internal teams to meet deadlines.

ConsultingInformation Technology
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Develop and execute CMC strategies for combination products
Assess PK/PD impact and support device bridging (e.g., vial → autoinjector)
Author and review CTD Module 3 and device technical documentation
Prepare submissions for IND, BLA, NDA, and other global applications
Respond to Health Authority inquiries on CMC and drug-device compatibility
Track documents and coordinate with internal teams to meet deadlines
Support global submissions (EU, APAC, LATAM)
Contribute to risk assessments and mitigation strategies

Qualification

Regulatory Affairs experienceCMC requirements knowledgeRegulatory submissions managementPK/PD concepts knowledgeInternational regulatory frameworksMedical device standards familiarityDesign Control documentation experienceBachelor’s degree in science

Required

Bachelor's degree in a scientific discipline
3-5 years Regulatory Affairs experience (pharma, biotech, or combination products)
Experience authoring and managing regulatory submissions
Strong understanding of CMC requirements for drugs/biologics
Knowledge of PK/PD concepts
Exposure to international regulatory frameworks

Preferred

Familiarity with medical device standards (ISO 13485, ISO 14971)
Experience with Design Control documentation (DHF, RMF)

Company

Sterling Engineering

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Sterling Engineering is an engineering company providing technical recruitment and engineering project services.
dateFounded in 1969
location
Westchester, Illinois, USA
people-size501-1000 employees
web-link
http://sterling-engineering.com

H1B Sponsorship

Sterling Engineering 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 (3)
2024 (6)
2023 (3)
2022 (1)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Dolores Connolly
CEO
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Recent News

Hartford Business Journal
With World War II-era roots, Barkhamsted machine shop Sterling Engineering aims to double in size amid broader turnaround effort
2025-01-28
Hartford Business Journal
Barkhamsted engineering group lands $33M component contract for Sikorsky
2024-12-20
Business Wire
Air Industries Group Subsidiary Sterling Engineering Corporation Receives $3.2M in New Contracts
2024-01-03
Company data provided by crunchbase