CMC Submissions Lead

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Job Description

Takeda Manufacturing USA, Inc. is seeking a CMC Submissions Lead in Cambridge, MA with the following requirements:

• Master’s degree in Pharmaceutical Sciences, Regulatory Affairs or related field plus 2 years of related experience.
• Knowledge of global regulatory guidelines, and understanding of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements for New Drugs.
• Understanding of the U.S. drug laws, FDA regulations/data expectations for pharmaceutical products, FDA standards for nonclinical testing and quality, data requirements and review process of New Drug Applications.
• Ability to create/maintain regulatory submission content plan, timeline, submission strategy, establish submission structure in electronic common technical document format for CMC Module 3 information.
• Written and oral communication skills in regard to scientific/pharmaceutical Dossiers.
• Ability to manage cross-functional authoring teams (lead kick-off, roundtable meetings, content/data reconciliation, verify content, functional approval).

Up to 20% telecommuting allowed.

Full time. $144,500 - $186,000 per year.

Apply online at and search for Req # R0132109.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time