You will lead regulatory CMC strategies for small molecule therapies at Acadia Pharmaceuticals. This role involves collaboration across teams to ensure compliance and successful product development.
Details
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Princeton, NJ; San Diego, CA; South San Francisco, CA, in-office three days a week
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$189,700—$237,100 USD
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10+ years in CMC Regulatory Affairs, 5 years in management
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Bachelor’s degree in life science or related field
The work
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Manage CMC regulatory affairs for marketed products and compounds in development
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Coordinate with R&D and other teams to develop CMC regulatory strategy
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Prepare high-quality CMC sections of INDs, CTAs, NDAs, and MAAs for submission
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Act as a key regulatory representative with external parties and regulatory agencies
