Director, Regulatory Site CMC

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 177,000 - 278,000; Full time

Benefits offered by this job

Perks are not listed in the ad

Job summary

Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This role requires 10+ years in biopharma with deep global HA regulatory experience, an advanced scientific degree, and proven ability to communicate regulatory strategy to cross-functional teams.

The position offers a hybrid work arrangement, competitive compensation, and opportunities to drive standardization and

Qualifications

• BS/BA degree in a scientific discipline; advanced degree preferred.
• 10+ years in biopharma with 8+ years regulatory CMC or regulatory device experience.
• Strong global HA regulatory experience beyond EU/US.
• Ability to communicate regulatory strategy to cross-functional teams.
• Excellent written and oral communication; leadership and teamwork.

Responsibilities

• Lead site-specific post-approval change management activities and regulatory submissions.
• Apply ICH Q12-based, risk-based approaches to post-approval changes.
• Promote standardized processes and tools for scalable site-based regulatory work.
• Explore automation to improve efficiency and repeatability in change control.
• Provide centralized regulatory support for multiple sites and external partners.
• Collaborate with external sites to align change control with global expectations.
• Ensure site compliance by risk-based evaluation of changes.
• Coordinate with global Regulatory CMC in cross-functional Change Review meetings.
• Implement streamlined workflows leveraging digital tools.
• Promote sustainable, scalable site-level regulatory operations.

Skills

Regulatory CMC

Global HA requirements

Leadership

Regulatory strategy

Communication

Education

BS/BA in a Scientific Discipline

MS/PhD preferred

Job description

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—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.
• 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.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. For information about our benefits, please click here.

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.

Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.