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CMC Regulatory Affairs Manager
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Full-time
- Job Title: Regulatory Affairs Manager
- Provide CMC regulatory strategy input and expertise in investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidance.
- Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.
- Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Track wise, Concur (expenses), and PowerPoint.
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
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