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Associate Director Or Director of Regulatory Affairs And Quality Assurance
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Full-time
- Job: Associated Director or Director of Regulatory Affairs and Quality Assurance
- DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials.
- We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join DermBiont.
- Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.
- Ability to assess R&D, non-clinical, and clinical documents for compliance to regulatory standards for GLP or GCP and to identify areas of non-compliance.
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