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Regulatory Affair-Lead/Sr/Jr

KRG Technologies

Entry levelBridgewater, NJ, us

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About KRG Technologies

KRG Technologies focuses on regulatory submissions for global health authorities.

What you'd do

Collaborate with global teams on publishing processes
Implement best practices for high quality deliverables
Develop regulatory documents like QCP and SWI
Monitor quality and mitigate risks in submissions

What they're looking for

Experience in Regulatory Affairs for pharma or medical/devic
Knowledge of regulatory publishing tools like eCTDXpress
Excellent verbal and written communication skills
GCP and 21 CFR part 11 knowledge