Senior Manager, GRO Regulatory Information Management, Hybrid / Remote
Company: Takeda Pharmaceutical
Posted on: January 27, 2023
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
that all information I submit in my employment application is true
to the best of my knowledge.
About the role:
At Takeda, we are a forward-looking, world-class R&D
organization that unlocks innovation and delivers transformative
therapies to patients. By focusing R&D efforts on four
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Join Takeda as a Senior Manager, GRO Regulatory Information
Management where you will be a key contributor responsible for
strategic thinking, and expert execution for the Information
Management portfolio and associated information repositories
serving the Global Regulatory Affairs organization and business
processes. This role will partner with business stakeholders as
well as liaise with Takeda Digital to ensure activities are
implemented to plans with Information integrity and according to
defined requirements and timelines.
You will also be accountable to curate Regulatory information to
ensure the highest quality to meet Health Authority standards and
Takeda's strategic needs. Oversees and ensures appropriate
resourcing of global information management projects; litigation
support; M&A; divestitures, etc.
As part of the GRO Regulatory Information Management team, you will
report to the Head, Regulatory Information Management and Digital
How you will contribute:
- Responsible to deliver Regulatory Information Management (RIM)
and associated processes and systems. Ensures information and data
standards are aligned with Takeda's strategic business requirements
(e.g. MDM, Regulatory strategy, Industry standards, HA
- Identifies opportunities for regulatory automation solutions
and may build out business cases for the evaluation and build of
- Ensures appropriate enterprise information and solution
integration points for consistent and compliant data flow.
- Partners closely with Digital to ensure fully integrated
regulatory systems, experience, and information model and
externally facing capabilities.
- Ensures there is a strategy and implementation plan for
seamless integration of information and content up and downstream
as well as across the governed regulatory systems portfolio.
- Lead and maintain a collaborative program of continuous
improvement within the regulatory solutions organization.
- Demonstrates a high level of leadership and expert
understanding of global RA information/data set regulations and
guidelines by applying interpersonal skills and expert RA knowledge
to address and overcome challenges that arise
- Successfully communicates and negotiates with international
Health Authorities as necessary, directly or indirectly
- Contributes to day-to-day GRA RIM initiatives (integration,
acquisitions/divestitures, IDMP,xEVMPD, SPOR, MDM).
- Collaborates with other IM leaders to deliver value-add
business-facing services to improve system user experience,
information accuracy, and timeliness
- Engage and lead with external regulatory forums and consortia
on innovation related to solutions and information for the needs of
Global Regulatory Affairs
- Ensures Takeda portfolio support with appropriate SLAs and
- Lead and define the development and execution of strategic and
change management initiatives.
- Oversees outsourcing activities performed by the external
vendor(s) for the management of regulatory information including
the development and oversight of robust KPIs and the oversight of
vendor activities for RIM system maintenance. Minimum
- Bachelor's degree or related experience is required. Scientific
or closely related field preferred.
- At least 8 years of experience in Pharmaceutical industry, with
more than 5 years in Regulatory Affairs, research and development,
- Significant experience in global drug development regulations,
regulatory submissions, lifecycle management, compliance, business
systems technology and process is required.
- Proven ability to liaise with Regulatory Agencies having served
as lead in Agency Interactions and industry forums, international
- Expert understanding of scientific principles and regulatory
information standards/requirements relevant to global drug
development and post-market support.
- Understanding in regulatory publishing and Information
management tools is required.
- Proven ability to provide strategic regulatory guidance to drug
development, registration, and post-market support teams.
- Able to deal with issues of critical importance, provides
regulatory advice and making reasoned decisions on regulatory
issues for which there may not be clear/specific regulatory
- Exercises good judgement in elevating and communicating actual
or potential issues to line management.
- Active participation in Agency/Industry groups/forums expected.
Recognized as an expert in the field. What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement More about us:
At Takeda, we are transforming patient care through the development
of novel specialty pharmaceuticals and best in class patient
support programs. Takeda is a patient-focused company that will
inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating
careers, encourages innovation, and strives for excellence in
everything we do. We foster an inclusive, collaborative workplace,
in which our teams are united by an unwavering commitment to
deliver Better Health and a Brighter Future to people around the
Base Salary Range: $ 130,200 - $186,000, based on candidate
professional experience level. Employees may also be eligible for
Short-term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
This position is currently classified as "Hybrid" or "remote" in
accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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 , Senior Manager, GRO Regulatory Information Management, Hybrid / Remote, Executive , Rochester, New York
Didn't find what you're looking for? Search again!