Director, Global Regulatory Project Management & Strategic Planning - Gastroenterology TAU - Remote
Company: Takeda Pharmaceutical
Posted on: January 25, 2023
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- Partners with the Global Regulatory Lead (GRL) on Global
Regulatory Teams (GRTs) to ensure global regulatory project plans
for programs / products of high complexity are established and
maintained, and plans & directs the seamless execution of the GRT
goals. Oversees and provides regulatory operational support for
programs in the Therapeutic Area Unit (TAU)
- Expertly leads cross functional project submission working
groups (SWG) to deliver successful submissions/filings and outcomes
with Health Authorities (HA) for highly complex, novel, and
critical programs by providing expert and effective Project
Management leadership, oversight, direction and planning.
- Directly supports TAU Regulatory Head by ensuring project
management and regulatory operational support for the therapeutic
areas product portfolio is effective, seamless and delivering to
expectations. Generates and delivers reports on portfolio metrics
and status updates with actionable insights ACCOUNTABILITIES
- Partner with the 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 highly complex
- 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
- Proactively drive GRT and SWG project teams, establish
appropriate level of urgency, and maintain focus on deliverables.
Lead teams to identify and recommend solutions to problems and
pathways to overcome barriers for strategy execution. Develop and
maintain integrated regulatory project plans and integrated SWG
- Directly support TAU Regulatory head with portfolio analytics
by creating, leading and delivering actionable assessment reports
and updates, as well as efficient processes for portfolio status
reviews. Provide project management support for TAU GRA department
meetings and project management leadership for business critical
projects and/or programs of very high complexity for TAU GRA
specific initiatives and workstreams as required/requested.
- Provide and oversee regulatory operational support activities
for programs supported by 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 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) across individual programs,
and across the TAU portfolio, as required. 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 across the TAUs portfolio of
- Elevate high impact business critical issues and potential
critical issues together with proposed plan of action, as
appropriate, in a timely manner to management.
- Drive continuous improvement across TAU GRTs by planning and
implementing changes through proactive engagements with GRA TAU
head. Identify and propose solutions for addressing potential
systemic bottlenecks and constraints across the portfolio.
- Supervise, coach and mentor staff. Provide leadership and
training to support Regulatory Project Managers' abilities to
deliver on all expectations and their professional development
- Actively contribute to the development, implementation and
continuous improvement of PM tools and processes for Global
Regulatory Project Management and Strategic Planning (RPM&SP).
Maintain lessons learned log across project portfolios; 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
- Responsible for demonstration of Takeda Leadership behaviors.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree required, emphasis in Science preferred.
Advanced degree preferred
- 10 yrs pharma experience with 8 yrs regulatory or 10 yrs
related field preferred
- PMP certification or equivalent strongly preferred
- Additional certification a plus: Regulatory (e.g. RAC or
equivalent), Change Management
- Demonstrated expert experience leading high performance teams,
managing staff and mentoring colleagues.
- Significant experience in global drug development regulations,
regulatory submissions, lifecycle management, compliance, business
systems technology and process is required.
- At least 2 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
- Proven ability to provide regulatory operational support and
- Able to deal with issues of critical importance, provides
regulatory operational advice and making reasoned decisions on
regulatory operational issues.
- Demonstrates leadership, problem-solving ability, flexibility
- Exercises good judgement in elevating and communicating actual
or potential issues to line management.
- Active participation in Industry groups/forums expected.
Recognized as an expert in the field.
- 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
- Excellent organizational skills, ability to multitask and with
attention to detail; capable of managing multiple projects within
- 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 direction to teams to
explore alternatives. "This position is currently classified as
"remote" in accordance with Takeda's Hybrid and Remote Work
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.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Rochester , Director, Global Regulatory Project Management & Strategic Planning - Gastroenterology TAU - Remote, Executive , Rochester, New York
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