Lead, Regulatory Intelligence and Policy Research
Company: Takeda Pharmaceutical
Posted on: January 26, 2023
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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 Lead, Regulatory Intelligence and Policy Research
where You will also Support global coordination for Takeda subject
matter expert participation on external workstreams and trade
groups. Support global coordination of Takeda Guidance commenting
and tracking, including region, country-specific, and ICH /
multi-national guidances and regulations. As well as drive
effective coordination and representation to ensure a Takeda one
How you will contribute:
- Global regulatory intelligence contact for key stakeholders
including therapeutic areas and regional teams as determined in
collaboration with regional EU, US, Japanese and EM Regulatory
- Global lead for regulatory policy research, including case
studies, data-driven policy support, regulatory data analysis,
visualization, and interpretation, public dataset identification
and characterization, and hypothesis testing. Work with Takeda
colleagues to publish research when appropriate.
- Support global coordination for Takeda subject matter expert
participation on external workstreams and trade groups. Support
global coordination of Takeda Guidance commenting and tracking,
including region, country-specific, and ICH / multi-national
guidances and regulations. Drive effective coordination and
representation to ensure a Takeda one voice policy.
- Represent Global Regulatory Policy & Intelligence and Global
Regulatory Affairs on internal and external forums/networks as
assigned. Provides impactful summaries and strategic advice, back
to the business, regarding assigned internal/external activities.
Provides leadership to influence the regulatory environment to meet
- Conduct strategic assessments of external regulatory changes
globally and work with subject matter experts within the Company,
to support the decision-making process to understand and prioritise
the regulatory risk & opportunities globally: develop the
strategies/positions and drive for appropriate action(s) relevant
to Takeda's Therapeutic Areas of focus and development projects.
- Contribute to the development and execute the Regulatory
Intelligence strategy. Keep abreast of internal and external
changes, trends, development and other dynamics relevant to the
regulatory environment that may impact Takeda's regulatory and/or
access strategies and disseminate information.
- Contribute to and lead the development and implementation of
appropriate regulatory intelligence management systems, processes,
and standards within GRPI, GRA, and across Takeda as assigned,
including vendor management and internal change control.
- Work closely and partner with GRPI colleagues and Subject
Matter Experts to plan and execute regulatory advocacy positions,
strategies and tactics and facilitate engagement on key topics of
- Support metrics development and maintain consistent oversight
of deliverables across GRPI. Keep all internal customers, partners
and stakeholders abreast of progress and provide interim updates on
ongoing activities and current initiatives. Ensure issues are
escalated when needed and encourage resolution at the appropriate
- Responsible for demonstrating Takeda Leadership Behaviors.
- Strong data science and data analysis skillsets, including
dataset identification and integration, data visualization, and
- Proficient in Python or R
- Strong familiarity with key public drug development and
regulatory datasets - clinicaltrials.gov, dailymed.gov, EPAR,
others - is prefered. Minimum Requirements/Qualifications:
- BSc, Advanced scientific related degree preferred; BA accepted
based on experience.
- A minimum of 8 years of pharmaceutical industry experience.
This is inclusive of 6 years regulatory experience or a combination
of 8 years regulatory and/or related experience in both development
and post-marketing phases.
- Solid understanding of regulations and guidance governing drugs
and biologics in all phases of development, including
post-marketing, in the US and/or EU (relevant to role), with a good
understanding of basic regulatory requirements and emerging
markets. Sound knowledge of intelligence tools and methods.
- Understands and interprets complex scientific issues across
projects and therapy area(s) of responsibility as it relates to
regulatory requirements, regulatory intelligence, policy and
strategy for region. Proven track record working with a major
regulatory agency, specific experience in government or policy is
- Excellent collaboration/relationship building, strong
influencing and negotiation skills, integrity and adaptability.
Outstanding written and oral communication skills as well as
managing and adhering timelines. Proven success at stakeholder
engagement across organizational levels and boundaries.
- Must have good working knowledge in 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.
- Generally strong in working well with others, within global
teams and communicating with senior leadership.
- Experience in managing relationships with CROs and/or
contractors also preferred. 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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $137,200 to $196,000, 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
Off. This posting is made in compliance with Colorado's Equal Pay
for Equal Work Act, C.R.S. 8-5-101 et seq
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, Trenton , Lead, Regulatory Intelligence and Policy Research, Other , Trenton, New Jersey
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