New · posted Nov 3
Takeda · Pharmaceuticals
Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience TAU
- Boston, MA
- Hybrid
- Full-time
- Director
The role
Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and drug development project management and regulatory affairs (e.g., clinical development, the prescription drug distribution process, etc)
Leadership
- Demonstrated ability to work across functions, regions and cultures
- Functional level leadership with the ability to inspire, motivate and drive results
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can engender credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple comprehensible terms
- Demonstrates leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
- Invests time in helping others to enhance their skills and perform at a higher level
Decision-making and Autonomy
Decision-making responsibilities:
- Provide input to highly complex decisions that impact the functional area
- Accountable for decision-making for designated function
- Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
- Accountable for providing input to and implementing vision and strategy for designated scope
Interaction
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions
Innovation
- Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
- Comfortable challenging the status quo and bringing forward innovative solutions·
- Ability to take risks implementing innovative solutions, accelerating time to market. Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
- Role models respect and inclusion, creating a culture that fosters innovation
Complexity
- Ability to work in a global ecosystem (internal and external) with a high degree of complexity·
- Ability to see and understand broader, enterprise-level perspective
What you need
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred
- Ideal candidate has a minimum of 8 years of related experience preferably with 4 yrs in regulatory
- Advanced education or credentialing in regulatory affairs and project management preferred
- Demonstrated expert experience leading high-performance teams and mentoring colleagues.
- Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
- At least one major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is required.
- Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
- Proven ability to provide regulatory operational support and guidance.
- Able to deal with issues of critical importance, provides regulatory operational advice and make reasoned decisions on regulatory operational issues.
- Demonstrates leadership, problem-solving ability, flexibility and teamwork.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
- Active participation in Industry groups/forums expected.
- Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging
- Excellent interpersonal and negotiation skills
- Demonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations. Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment
- Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
- Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Analytical and problem-solving skills with the ability to identify issues and opportunities and provide directions to teams to explore alternatives.
- Expertise with project management related software and tools (e.g. Planisware, Microsoft Project, OnePager, Office Timeline, SharePoint etc).
ACCOUNTABILITIES
- Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for complex programs.
- Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
- Proactively drive GRT and SWG project teams, establish appropriate level of urgency, and maintain focus on deliverables. Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. Develop and maintain integrated regulatory project plans and integrated SWG plans.
- Provide and oversee regulatory operational support activities for assigned programs within the TAU. Ensure out-sourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards. Liaise and proactively engage with third party stakeholders to ensure smooth, effective and timely work flows. Operational support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support for health authority meetings, coordinating briefing book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.)
- Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) for assigned programs. Collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.
- Drive decision making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones for assigned programs.
- Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management.
- Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose solutions for addressing potential systemic bottlenecks and constraints. Conduct lessons learned sessions for assigned programs; track project variances and identify root causes; detect, raise awareness and develop plan to address systemic concerns/issues.
- Consult, support, advise and contribute to Takeda’s body of Regulatory Project Management Knowledge and Project Management processes.
- Provide training and support to other RPMs as required.
- Responsible for demonstration of 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
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
Location
- This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Boston, MA
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 level with the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $154,400 | — | $242,550 |
| Massachusetts (middle half) | $198,500 | $198,500 | $206,875 |
| All US (middle half) | $198,500 | $198,500 | $221,000 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 41 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 54 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership24
- Regulatory submissions4
- Documentation and SOPs3
- Data and digital systems2
- GMP and compliance1
- Lab testing and methods1
- Investigations and CAPA1
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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 Project Management and Strategic Planning - Neuroscience TAU at Takeda
Open until filled. $154K–$243K a year, employer provided.