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:

1. Master’s degree in Pharmaceutical Sciences, Regulatory Affairs or related field plus 2 years of related experience.
2. Prior experience must include:
   1. Knowledge of global regulatory guidelines, and understanding of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements for New Drugs.
   2. 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.
   3. 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.
   4. Written and oral communication skills in regard to scientific/pharmaceutical Dossiers.
   5. 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 on-line at and search for Req # R0132109.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time