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Job Description

About the role:

The Director 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, vaccines, plasma-derived therapies, 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.

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, biologics, vaccines, and plasma-derived therapies.

• 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 relevant 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.  Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered).  

• 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.

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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:

$174,500.00 - $274,230.00

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.