Takeda · 4 hours ago
Director, Regulatory Site CMC
Boston, MA
Full-time
Hybrid
Director/Executive
$174K/yr - $274K/yr
10+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level, supporting diverse modalities and driving standardization and sustainability.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Hiring Manager
Anula Aboobacker
Responsibilities
Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements
Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes
Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities
Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions
Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics
Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations
Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale
Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings
Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact
Promote sustainable practices and scalability in site-level regulatory operations
Qualification
Required
BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred
10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA
Strong practical experience with global HA requirements, beyond EU/US
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
Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines
Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management
Understands who is responsible for different decisions and escalates as necessary
Applies directions taken by the company
Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork
Intentionally promotes an inclusive culture
Applies given prioritization framework with limited support
Excellent written and oral communication skills required
Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (40)
2023 (39)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
BioWorld Financial Watch
2025-12-21
Company data provided by crunchbase