Actithera, Inc.
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Biotech • Pharmaceutical
Lead global regulatory strategy and submissions for radiopharmaceutical (RLT) portfolio. Own briefing books, IND/CTA filings and amendments, ensure ICH/GMP and radiation-specific compliance, engage health authorities (FDA, EMA, PMDA), coordinate clinical/CMC/quality teams, monitor regulatory landscape, and mentor regulatory staff to secure timely approvals.
