Executive Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs, GI
Posted on: January 25, 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.
Are you looking for a patient-focused company that will inspire you
and support your career? If so, be empowered to take charge of your
future at Takeda. Join us as a Executive Director, Global
Regulatory Portfolio Lead, Global Regulatory Affairs - GI .
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As an Executive Director working on the
Global Regulatory Affairs GI team, you will be empowered to provide
leadership and development to global regulatory leads to ensure
innovative and robust global regulatory strategies are developed to
maximize regulatory success and minimize time to approval, and a
typical day will include:
- Provides leadership and development to global regulatory leads
to ensure innovative and robust global regulatory strategies are
developed to maximize regulatory success and minimize time to
- Develops best practices and creates a strong regulatory
community across the broader Global Regulatory Affairs (GRA)
- Serves as an influential leader within Takeda and external to
Takeda, contributing to cross-functional initiatives and
influencing the field as applicable. ACCOUNTABILITIES
- The Executive Director will be responsible for managing direct
reports and overseeing all global and US submission for an assigned
portfolio of projects . These include ensuring that the direct
reports have defined, developed and clearly communicated
appropriate global strategies to maximize global regulatory
success. The role may serve as an interim GRL on a global project
team on a as needed basis.
- Partner with direct reports to ensure global market access
consideration are being addressed and provide senior strategic
input to interactions with joint regulatory/health agency/HTA
bodies on product specific value evidence topics, as
- Ensures line management and key stakeholders are apprised of
developments that may impact regulatory success, exercising sound
judgement and communicating in a professional and timely manner.
Demonstrates ability to anticipate risks and responsible for
developing solutions to identified risks and discussing with direct
reports and management; understands probabilities of technical
success for the solutions.
- Effectively represent the Global Regulatory Affairs (GRA)
function in senior level interactions at internally governance
technical review committees, key global health authority meetings
and external partners.
- Accountable for working with regulatory regional leads, other
functions and vendors to ensure global regulatory submissions are
provided to local Takeda affiliates in compliance with local
regulations and to maintain compliance for products.
- Participates with influence in or leads departmental and
cross-functional task-forces and initiatives. Influence non-direct
reports within GI Area, across GRA and across R&D.
- Provide regulatory strategy support to diligence for licensing
opportunities as appropriate
- Monitor and anticipate trends that impact both the regulatory
and access environments to strengthen product development plan(s)
and adopt regulatory strategies in a timely manner.
- Responsible for demonstrating Takeda leadership behaviors.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and
global regulatory strategy experience. Leadership
- Demonstrated ability to work across functions, regions and
- 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
- 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
- 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
- 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-making, complexity of decisions,
impact of decisions, problem-solving) 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
- 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
- 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
- Deep expertise required
- Ability to see and understand broader, enterprise level
perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree in a scientific subject area (e.g. MSc, PhD,
PharmD, MD) with global oncology regulatory experience preferred.
- 12+ years of pharmaceutical industry experience. This is
inclusive of 10 years of regulatory experience or combination of 8+
years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing
components of regulatory submissions.
- Solid working knowledge of drug development process and
regulatory requirements. Knowledge of FDA, EU, Canada, ROW and
post-marketing a plus.
- Understand and interpret complex scientific issues across
multiple projects as it related to regulatory requirements and
- Understands and interprets scientific data as it relates to
regulatory requirements and strategy for assigned projects and
provides knowledge and expertise to guide team in established and
building appropriate global regulatory strategy.
- Strong oral and written communications, managing and adhering
to timelines, negotiation skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence in
the area of regulatory strategy such as understanding broad
concepts within regulatory affairs and implications across the
organization and globally; proactively identifies regulatory
issues; offers innovative
- Solutions and strategies, including risk mitigation
- Must work well with others and within global teams.
- Able to bring working teams together for common
- Acceptable and independent skills in the area of regulatory
strategy such as understanding broad concepts within regulatory
affairs and implications across the organization and globally;
proactively identifies regulatory issues; offers creative solutions
and strategies, including risk mitigation strategies. WHAT TAKEDA
CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs Location and Salary Information:
- This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
- Base Salary Range: $240K-$270K based on candidate professional
experience level. Employee may also be eligible for Short Term
and/or Long Term incentive benefits. Employees are eligible to
participate in Medical, Dental. Vision, Life Insurance, 401(k),
Charitable Contribution Match, Company Holidays, Personal &
Vacation Days . click apply for full job details
Keywords: Takeda, Cambridge , Executive Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs, GI, Executive , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!