Manager/Senior Manager, Global Regulatory Project Management and Strategic Planning - Rare Genetics
Company: Takeda Pharmaceutical
Posted on: January 26, 2023
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description OBJECTIVES
- Partners with the Global Regulatory Lead (GRL) on Global
Regulatory Teams (GRTs) to ensure global regulatory project plans
for programs/products of medium complexity are established and
maintained, and plans & directs the seamless execution of the GRT
- Leads cross functional project submission working groups (SWG)
to deliver successful submissions/filings and outcomes with Health
Authorities (HA) for early to late phase programs by providing
effective Project Management leadership, oversight, direction and
- Directly supports program GRL by ensuring project management
and regulatory operational support for the asset is effective,
seamless and delivering to expectations. Performs regulatory
operational activities and directly oversees vendors providing
operational support for assigned programs.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 moderately
complex programs and submissions.
- 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.
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 (eg GPT members, Regulatory
Leadership. TAUs & BUs) as appropriate, through both scheduled and
- 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
- Provide training and support to other RPMs as required.
- Responsible for demonstration of Takeda Leadership
behaviors.EDUCATION, BEHAVIORAL, COMPETENCIES AND SKILLS
- Bachelors degree required. Emphasis in Science preferred.
Advanced degree preferred
- Ideal candidate has 6 years related experience, preferably with
4 years 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 preferred.
- 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.
- 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
- 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
- Expertise with project management related software and tools
(eg MS Project, OnePager, Office Timeline, SharePoint etc).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 Massachusetts - Virtual Worker Type Employee Worker
Sub-Type Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Reading , Manager/Senior Manager, Global Regulatory Project Management and Strategic Planning - Rare Genetics, Executive , Reading, Pennsylvania
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