Company:
Takeda Pharmaceutical
Location: Boston
Closing Date: 25/10/2024
Salary: £125 - £150 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
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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.
- Prior experience must include:
- 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 on-line at and search for Req # R0132109.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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Takeda Pharmaceutical