New · posted Nov 3
Takeda · Pharmaceuticals
Associate Director, Global Regulatory Affairs, Inflammation
- Cambridge, MA
- Hybrid
- Full-time
- Director
The role
Objective / Purpose
- Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
What you need
Education & Competencies
- Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
- 6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experience
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
- Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Must work well with others and within global teams.
- Able to bring working teams together for common objectives.
- Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Accountabilities
- The Associate Director will be responsible for highly complex or multiple projects. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
- Ensures global regulatory strategies defined within the Global Regulatory Team (GRT) are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
- Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs.
- Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
- Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
- Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
- Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
- Responsible for demonstrating Takeda leadership behaviors.
Pay
$154,400 – $242,550 a year
Employer providedU.S. Base Salary Range
$154,400.00 - $242,550.00
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.
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.
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
USA - MA - Cambridge - Binney St
Job Exempt
YesIt 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.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Massachusetts28 roles publishing pay
Director roles in the US94 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $154,400 | — | $242,550 |
| Massachusetts (middle half) | $201,875 | $232,500 | $264,250 |
| All US (middle half) | $202,625 | $232,500 | $264,000 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 302 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Regulatory submissions10
- GMP and compliance3
- Documentation and SOPs3
Company hiring pulse
Takeda on Regulatory Jobs
- 66
- Open roles
- 63
- Distinct roles
- 16
- Locations
By discipline
- Regulatory26 39%
- Clinical21 32%
- Quality18 27%
By level
- Director39 59%
- Senior & Principal12 18%
- Manager9 14%
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Associate Director, Global Regulatory Affairs, Inflammation at Takeda
Open until filled. $154K–$243K a year, employer provided.