Director, Regulatory Site CMC

BioSpace; Boston (MA); Hybride; USD 174 500 - 274 230; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid volunteer time off

Well-being benefits

Résumé du poste

A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in the biopharmaceutical industry, with a strong background in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between $174,500 and $274,230 alongside comprehensive benefits.

Qualifications

• 10+ years of overall biopharmaceutical/device industry experience.
• 8+ years of direct Regulatory CMC or Regulatory Device experience required.
• Proven ability to understand and communicate regulatory strategy.

Responsabilités

• Lead site-specific post-approval change management activities.
• Drive the adoption of standardized processes and tools.
• Explore and implement automation technologies.
• Ensure site compliance with global regulatory requirements.
• Facilitate alignment with global Regulatory CMC.

Connaissances

Global HA requirements understanding

Attention to detail

Leadership

Collaboration

Communication skills

Formation

BS/BA Degree in a Scientific Discipline

Advanced Degree (M.S., Ph.D.)

Description du poste

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.


• 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.


• 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.

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.

Location

Boston, MA

U.S. Base Salary Range

$174,500.00 - $274,230.00

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.

U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

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.