CMC Submissions Lead
4 days ago
Takeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in Cambridge, MA.
Key Responsibilities:- Develop and maintain regulatory submission content plans, timelines, and submission strategies.
- Establish submission structures in electronic common technical document format for CMC Module 3 information.
- Lead cross-functional authoring teams to create and verify content.
- Manage data requirements and review processes for New Drug Applications.
- Master's degree in Pharmaceutical Sciences, Regulatory Affairs, or a related field.
- 2 years of related experience, including knowledge of global regulatory guidelines and Good Documentation Practices.
- Excellent written and oral communication skills.
- Up to 20% telecommuting allowed.
- Full-time position with a competitive salary range of $144,500 - $186,000 per year.
Apply online at [insert link] and search for Req # R Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
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