Regulatory Affairs Specialist - Global Submissions & Strategy
Job in
Maryland Heights, St. Louis city, Missouri, 63043, USA
Listed on 2026-07-10
Listing for:
Curium Pharma
Full Time
position Listed on 2026-07-10
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
Job Description & How to Apply Below
Curium is seeking a Regulatory Affairs Specialist to support US FDA submissions (NDAs/ANDAs/DMFs) and international drug applications. You will plan, author and manage eCTD filings for marketed products and coordinate with cross‑functional teams to ensure regulatory compliance.
Responsibilities include assessing post‑approval changes, preparing labeling updates, maintaining regulatory databases, and mentoring entry‑level staff while staying current with evolving guidelines.
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