Job Number:
HC-03627
Date Posted:
March 8, 2026
Position Title:
Associate Director, Global Regulatory Affairs CMC
Party:
N/A
Office Code:
Office/Company:
Takeda Pharmaceuticals
Reports To:
Location:
Boston, MA
Contact:
Salary:
$153,600.00 – $241,340.00
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.Develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy.BS/BA Degree in a Scientific Discipline; Advanced Degree (M.S., Ph.D., etc.) preferred.
Responsibilities:
• Develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
• Develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy.
• Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
• With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters.
• Interacts directly with international Health Authorities on administrative procedural topics, as required.
• Fosters constructive working relationships when interacting with internal and/or external colleagues.
Qualifications:
• BS/BA Degree in a Scientific Discipline; Advanced Degree (M.S., Ph.D., etc.) preferred.
• 10+ years of overall biopharmaceutical/device industry experience with 5+ 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.
• Analyzes issues with attention to detail.
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
Instructions:
Email to apply
Other:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
