Director Global Regulatory Affairs, Audits, Inspections and Compliance
Company: Takeda Pharmaceutical
Posted on: November 26, 2022
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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 Director Global Regulatory Affairs, Audits,
Inspections and Compliance where you will be responsible for
overseeing the support to audits and inspections related to the
Global Regulatory Affairs (GRA) activities including: strategy,
inspection readiness, inspection support, post inspection
activities and continues improvement. Leads the interaction and
collaboration with various stakeholders including but not limited
to the R&D QA, Global QA,GPSE, GCP, CROs and LOCs partnering
with Regional Compliance. Responsible for implementing and
executing the internal audits program for the Global Regulatory
Affairs organization including activities performed by CRO's and
external partners on behalf of Takeda's Global Regulatory Affairs.
And, Ensure alignment with global strategic initiatives related to
regulatory quality and compliance.
You will also have responsibility for the Global Regulatory Affairs
Compliance and Quality processes. Supports the assessment and
implementation of the Global Regulatory Affairs actions resulting
from new/updated regulations. Act as strategic partner with the
Global Regulatory Affairs organization in the development and
monitoring of regulatory labelling and CMC compliance processes and
systems. Identify potential areas of compliance vulnerabilities and
risks related to GRA functions and processes and develop strategic
initiatives and/or mitigation plans to reduce risk.
As part of the Global Regulatory Affairs, Audits, Inspections and
Compliance team, you will report to the Senior Director, Head of
Compliance, Global Regulatory Affairs.
How you will contribute:
- Responsible for demonstrating Takeda leadership behaviors.
- Lead the Global Regulatory Affairs activities related to audit
- Lead and support critical Compliance Global Regulatory Affairs
- Act as the primary contact to Quality and Global Quality
organizations for audits, inspections and GxP/regulatory
- Ensure effective collaboration with and serve as an GRA
compliance advisor to other functional partners within Global
Quality and the Global Development Office/GDO (PV, Clinical
Development Operations, Clinical Supplies Management, and
Development Support) representing GRA and support the culture of
- Lead the GRA cross functional workstream to support the
GRA-Partnerships related actives (TDOM-TTDOM and others
- Support the process to assess Regulatory Compliance
requirements, new/revised global regulatory GxP requirements and
identify the impact to the Takeda's operation.
- Co-development of relevant GRA metrics to track regulator
commitments ( audits and inspections, and Health Authority
requests). Communicate issues/trends to GRA leadership.
- Partner with the Compliance QMS and Regional Compliance
organizations to develop and implement the Quality elements into
the GRA processes and systems.
- Collaborate and build relationships with regional/LOC team
members for the development and implementation of GRA compliance
- Support the labelling and CMC functions on the implementation
of the regulatory compliance processes and systems.
- Support the RA LOCs on the implementation of the Quality and
Compliance processes and systems.
- Support the implementation of the regulatory compliance related
elements in the GPSE and GCP processes and systems.
- Consistently foster and exhibit exemplary leadership behaviors,
inclusiveness and ethics.
- Inspection/Audits: Responsible for GRA, CRO's and GRA external
partners and LOC regulatory inspection or internal audit readiness
for dedicated GRA/QMS/GxP Inspections/audit;
- Ensure all inspection and audit issues related to Global RA and
findings are addressed adequately; Partner with GDO, LOCs and other
global cross-functional partners in local inspection/audit
activities as needed; and oversee corrective and preventive action
plans (CAPAs). Support regional/Los in addressing issues identified
in CAPAs as needed.
- Identify and lead the implementation of GRA opportunities for
automation and process excellence. Minimum
- Bachelor degree in a science or business-related field, MSc or
- At least 10 years of experience in the pharmaceutical industry,
with 3 years in regulatory Affairs, research and development,
- Familiarity with inspection and audit procedure.
- Ability to identify proactively and anticipate risk of
non-compliance in a complex environment.
- Demonstrated knowledge of global health authorities,
regulations, product approval and lifecycle processes for major
markets and of pharmaceutical and regulatory affairs requirements
- Practical operational experience of working across disciplines
and across multiple regions. Experience working within a global
ream framework and a multi-cultural environment.
Efficiently/actively manages conflict in a tactful, diplomatic way,
seeking effective solutions for all parties.
- Able to manage both time and priority constraints and to manage
multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous
information and the impact on products and process and to
effectively communicate complex issues both verbally and in
- Strong communication skills with the ability to express oneself
clearly and concisely to a variety of audiences. Ability to
understand/analyze/synthesize and communicate to internal/external
- Must be able to lead cross-functional and cross regional teams
and deliver results in a matrix organization. Excellent
organizational skills and ability to prioritize as well as Project
- Willingness to travel to various meetings, including oversight
- Requires approximately up to 10 % travel What Takeda can offer
- 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: $160,300 - $229,000, 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
This position is currently classified as "hybrid" 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.
Keywords: Takeda Pharmaceutical, Cambridge , Director Global Regulatory Affairs, Audits, Inspections and Compliance, Executive , Cambridge, Massachusetts
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