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Assistant / Associate Director, Pharmaceutical Development
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- As the first company to fully harness the power of RNA technology for human therapeutics, Ionis' platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.
- While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive.
- The ideal candidate will be an independent self-starter with experience in late-stage drug product development; aseptic manufacturing for injectables and authoring clinical stage drug product dossiers, including regulatory strategy.
- Author and compile drug product CMC sections of US FDA and Ex-US regulatory applications, and submissions of IND and CTA, including amendments and annual updates.
- Contribute to standardizing and preparing information or responses as requested by regulatory agencies, QPs, and other authorities.
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