Barrington James · 9 hours ago

Regulatory Affairs Specialist

United States

Contract

Remote

Mid Level

3+ years exp

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Harrison Moore

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Responsibilities

Provide support to a CRO on their submission work.

Work on complex CTA and IND submissions.

Have recent experience working with Health Canada for the filing of a CTA for their first in-human submissions.

Assist with IND filings or Pre-IND meeting requests for the FDA.

Work on regulatory gap assessments.

Provide advice & guidance on streamlining regulatory processes.

Assist the regulatory function where needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsCTA submissionsHealth CanadaIND submissionsFDA regulationsRegulatory gap assessmentsRegulatory processesAdvice & guidance