Director, Regulatory Site CMC

Takeda; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and aligning with global regulatory expectations. You will apply ICH Q12 principles, drive standardized processes, and explore automation to improve predictability and efficiency in regulatory activities.

You will communicate regulatory strategy to drug development, registration, and post‑market teams, leveraging strong leadership and collaboration

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 8+ years of direct Regulatory CMC or Regulatory Device experience required.
• 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.
• Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.
• Applies directions taken by the company and escalates issues as necessary.
• Demonstrates leadership, problem‑solving ability, flexibility and teamwork; promotes an inclusive culture.
• Excellent written and oral communication skills; demonstrated leadership and collaboration skills.

Responsibilities

• Lead site‑specific post‑approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes).
• 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.

Skills

Leadership

Communication

Collaboration

Negotiation

Problem solving

Teamwork

Prioritization

Inclusive culture

Education

BS/BA in Scientific Discipline

MS/PhD preferred

Job description

About the role

At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life‑changing therapies to patients worldwide.

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—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability.

This position leverages ICH Q12 principles to streamline post‑approval change management and explores automation to enhance predictability and repeatability in regulatory processes.

We are looking for someone with strong practical experience with global HA requirements, beyond EU/US, who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post‑market support.

Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post‑market support teams.

How you will contribute

• 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.

Minimum Requirements / 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 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.
• 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.

Location

Boston, MA

EEO Statement

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.