Job Number:
HC-03625
Date Posted:
March 8, 2026
Position Title:
Senior Manager, Global Regulatory Affairs CMC
Party:
N/A
Office Code:
Office/Company:
Takeda Pharmaceuticals
Reports To:
Location:
Boston, MA
Contact:
Salary:
$137,000.00 – $215,270.00
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.Leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
Responsibilities:
• Leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
• RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
• Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.
• Ability to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
Qualifications:
• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Analyze issues with attention to detail.
• Ability to assess alternative approaches.
Instructions:
Email to apply
Other:
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
