Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience TAU

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Job Description

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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred
• Ideal candidate has 8 yrs 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).

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 

Location

• This position is currently classified as “hybrid” in accordance with 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. 

For Location:

Boston, MA

U.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.

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

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.